· Web viewGCS Glasgow Coma Score ICU Intensive Care Unit VAP Ventilator Acquired Pneumonia SBT...

The ENIO Study. Clinical Trial identifier: NCT03400904

Extubation strategies in Neuro-Intensive care unit patients and

associations with Outcomes (ENIO) –a multicentre international

observational study

Version 1.7 3rd July 2017 1


Sponsor/Funder:European Society of Intensive Care Medicine19 rue BelliardB-1040, BrusselsBelgium

Chief Investigator:Pr Karim ASEHNOUNE, M.D., Ph.D.Department of Anesthesia and Critical Care.Hôtel Dieu. 1 place Alexis Ricordeau. 44093 Nantes Cedex 9, France.Tel: (+33)240087381Fax: (+33)240087382e-mail: [email protected]

International investigator:Dr Raphaël CINOTTITel: (+33)240084731Fax: (+33)240087382e-mail: [email protected]

Steering Committee members:(in alphabetical order)

Pr Paolo PELOSISan Martino Hospital, University of Genoa, Genoa, [email protected]

Dr Fabio TACCONEDepartment of Intensive Care, Erasme Hospital, Brussels, [email protected]

Pr Samir JABERDepartment of Intensive Care, St Eloi Hospital, Montpellier, [email protected]

Pr Romain PIRRACCHIODepartment of Intensive Care, Hôpital Européen Georges Pompidou, APHP, Paris, [email protected]

StatisticianPr Romain PIRRACCHIODepartment of Intensive Care, Hôpital Européen Georges Pompidou, APHP, Paris, [email protected]


mailto:[email protected]






Table of contents

1. SUMMARY…………………………………………………………………………...6

1.1Rationale……………………………………………………………………...6

1.2Objective……………………………………………………………………...6

1.3Study design………………………………………………………………….6

1.4Study population……………………………………………………………..6

1.5Main study parameters………………………………………………………6

1.6Nature and extend of the burden and risks associated with

participation…………………………………………………………………..6

2. INTRODUCTION AND RATIONALE………………………………………………7

2.1Mechanical ventilation and Brain Injury……………………………………7

2.2Weaning of mechanical ventilation after Brain Injury…………………….7

2.3Extubation Management…………………………………………………….7

2.4Tracheostomy Management………………………………………………..8

2.5Aim of the study……………………………………………………………...8

3. STUDY DESIGN……………………………………………………………………..9

3.1Study Flowchart………………………………………………………………9

4. STUDY POPULATION…………………………………………………………….10

4.1Population……………...……………………………………………………10

4.2Inclusion criteria…………………………………………………………….10

4.3Exclusion criteria……………………………………………………………10

4.4Sample Size calculation……………………………………………………10

5 METHODS...…………………………………………………………………………….12

5.1Study Endpoints…………………………………………………………….12

5.1.1 Primary Study Endpoint

5.1.2 Secondary Study Endpoint

5.2Randomization……………………………………………………………...12

5.3Study Procedures…………………………………………………………..12

5.4Data Collection……………………………………………………………...13

5.5Withdrawal of individual subjects…………………………………………13

6 STATISTICAL ANALYSIS……………………………………………………………..14

7 ETHICAL CONSIDERATIONS………………………………………………………..15



7.1Regulation Statement………………………………………………………15

7.2Ethical and Regulatory authorities’ approval…………………………….15

7.3Patient Information…………………………………………………………15

8 ADMINISTRATIVE ASPECTS AND PUBLICATIONS……………………………..16

8.1Handling and storage of data and documents…………………………..16

8.2Public disclosure and publication policy………………………………….16

8.3Organization………………………………………………………………...17

9 REFERENCES………………………………………………………………………….18

10 CASE REPORT FORM………………………………………………………………..19

11 APPENDICES…………………………………………………………………………..30

11.1 Appendix 1. Bundle of neurologic, respiratory and weaning

management………………………………………………………………..31

11.2 Appendix 2. Glasgow Coma Score, WFNS grade, Fisher Grade,

Glasgow Outcome Scale………………………………………………….32

11.3 Appendix 3. Definitions…………………………………………….34

11.4 Appendix 4. Patient information sheet (in English)……………..37

11.5 Appendix 5. Patient informed consent (in English)……………..39

11.6 Appendix 6. Next-of-kin information sheet (in English)…………40

11.7 Appendix 7. Next-of-kin informed consent (in English)…………42



LIST OF ABBREVIATIONSMV Mechanical Ventilation WLST Withdrawal of Life Sustaining

Treatment

BI Brain Injury GCS Glasgow Coma Score

ICU Intensive Care Unit VAP Ventilator Acquired Pneumonia

SBT Spontaneous Breathing Test PaO2 Partial Pressure in Dioxygen

PCO2 Partial pressure in carbon dioxide LOS Length of Stay

CRF Case Report Form ESICM European Society of Intensive

Care Medicine

IRB/IEC Institutional Review Board/

Independent Ethics Committee

LASSO Least Absolute Shrinkage

Selection Operator

PIN Patient Identification Number SFAR Société Française d’Anesthésie-

Réanimation

PEEP Positive End Expiratory Pressure RASS Richmond Agitation Sedation

Scale

SAS Sedation Agitation Scale NA Not Applicable

WFNS World Federation of Neuro-

Surgeons

CPAP Continuous Positive Airway

Pressure

ICDSC Intensive Care Delirium Screening

Checklist

NYHA New York Heart Association

PtiO2 Brain Tissue Oxygenation



1. SUMMARY1.1 RationaleProlonged mechanical ventilation (MV) is common in patients with severe Brain Injury

(BI). Guidelines for the management of extubation are largely lacking for these

patients, and the role of tracheostomy is highly uncertain. More important, data on

practice of management of extubation is yet underreported, as is the use of

tracheotomy in these patients.

1.2 Objective

The objective of this prospective observational study is to describe the management

of extubation and tracheostomy in intensive care unit (ICU) patients with BI. We

sought to describe the incidence of extubation failure and the rate of tracheostomy.

1.3 Study design

The “Extubation strategies in Neuro-Intensive care unit patients, and associations

with Outcomes (ENIO)” is an observational multicentre international cohort study.

1.4 Study population

We will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and

with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission.

The inclusion period will last 6 months in total, and each centre is expected to include

at least 24 patients during this period. With over 60 ICUs participating worldwide, we

expect to include 1500 patients.

1.5 Main parameters

Parameters to be collected include: general neurological management, ventilatory

management, general ICU complications, specific data on extubation and

tracheostomy, general in-ICU outcomes and in-hospital mortality.

1.6 Nature and extent of the burden and risks associated with participation

Because of the observational design of the study using routinely collected data, there

is no additional burden for the patient. Collection of data from ICU charts and/or

(written or electronic) medical records systems is of no risk to the patients.



2. INTRODUCTION AND RATIONALE

2.1 Mechanical ventilation and Brain Injury

After BI, mechanical ventilation is often required, to prevent aspiration, and to prevent

and treat hypoxemia, hyper and hypocapnia which induces secondary brain insults

[1]. Also patients with BI represent a rather modest ratio of patients in the ICU, they

clearly display a longer duration of MV and poorer outcome [2].

2.2 Weaning from mechanical ventilation after BI

To the best of our knowledge, patients with BI have not been evaluated in the latest

guidelines [3], and no specific recommendations are available to help the attending

physician for the weaning from mechanical ventilation in BI patients. Extubation

remains nonetheless a major issue in this population since extubation failure ranges

from 8% [4], but could be up to 38% [5]. Some authors have pointed out that the

extubation process was challenging in severe BI patients because both extubation

failure and delayed extubation are common in this population and increased

morbidity and mortality [6]. In particular, delayed extubation leads to ventilator-

associated pneumonia (VAP) without decreasing the risk of extubation failure [6]. The

prevention of delayed extubation is therefore one of the most promising intervention

targets for improving outcome, but the predictors of successful extubation are

controversial. Indeed, the usual predictors of successful extubation when patients

have passed a spontaneous breathing trial (SBT) do not apply because the ability to

protect the airway and the neurological status are impaired, or impossible to evaluate

because of an altered neurological status at the time of extubation in patients usually

that cannot collaborate [7].

2.3 Extubation management

There are few studies, mainly monocentric, regarding extubation readiness in BI

patients [5, 6]. Also, the extubation management is usually not detailed, or focuses

mainly on respiratory parameters [5], and are not are not specifically designed for

studying weaning process [8]. Scores that may help the attending physician in the

extubation process are lacking. The present study has the potential to assess the

respiratory, airway and neurological items that could enhance successful extubation



in patients with altered neurological status.

2.4 Tracheostomy management

Tracheostomy is advocated to facilitate weaning [9]. However, patients that would

benefit of tracheostomy as well as the timing of tracheostomy, are unknown and few

data on the subject suffer from major bias [10]. There are currently no prospective

observational study focusing on this topic, which remains of major clinical

importance. The proposed study has the potential to describe the management and

to help in the screening of patients who could benefit from this technique.

2.5 Aim of this study

The aim of the study is to assess the exact incidence of extubation failure in patients

with BI, owing to the lack of homogeneity in the current literature and the recent

changes in the definition of extubation failure [11]. The present study aims at

characterizing the current practices about extubation and tracheostomy management

in BI patients, to provide meaningful help for attending physicians, but also delineate

the associations on the outcome.



3. STUDY DESIGNThis is a prospective multi-center international observational cohort study.

3.1 Study Timechart

Version 1.7 3rd July 2017

Expected extubation and/or tracheostomy

CRF

Data acquisition from extubation/tracheostomy to ICU discharge

End of study

CRF

Data acquisition from Day 1 to extubation/tracheostomy

Enrollment in the ENIO study

End of Intra-Cranial Hypertension Phase

Brain InjuryMechanical Ventilation ≥ 24 hours

9


4. STUDY POPULATION4.1 Population We assume that each centre will include 4 patients per month with BI undergoing

extubation or tracheostomy, over a 6 months’ period. According to our sample size

calculation (see 4.5), 63 centres are needed to perform the inclusions. Patients will

be included in a consecutive manner, during a 6 months’ period in each centre. This

study is focused in specific neuro-ICU units who deal with patients with traumatic

brain injury, intra-cerebral haemorrhage, sub-arachnoid haemorrhage, and ischemic

stroke. The goal of 4 patients per month in each unit seams therefore very feasible.

4.2 Inclusion criteria

- Age ≥ 18 years’ old

- Patients admitted in a ICU for a central neurological pathology, listed as follows,

with estimated or clinically evaluated Glasgow Coma Score ≤12 before endo-

tracheal intubation, with anomaly on brain CT-scan and requiring effective invasive

mechanical ventilation ≥ 24 hours are eligible to the study:

- Traumatic Brain Injury

- Aneurysmal Subarachnoid haemorrhage

- Intra-Cranial Haemorrhage

- Ischemic Stroke

- Central Nervous System Infection (Abscess, Empyema, Meningitides,

Encephalitis…)

- Brain Tumour

-Patient with an attempt of extubation and/or performance of a tracheostomy

4.3 Exclusion criteria- Patients < 18 years’ old

- Patients with ongoing pregnancy

- Patients with spine cord injury above T4

- Resuscitated cardiac arrest

- Withdrawal of Life-Sustaining Treatment (WLST) in the first 24 hours

4.5 Sample size calculation



According to previously data, the incidence of extubation failure ranges from 10 to

38% [4, 5]. More recent data suggest an average incidence of 22% extubation failure

[12]. We wish to include 1500 patients with an attempt of extubation and/or performance of tracheostomy in order to screen 300 patients with an extubation

failure which would allow us to evaluate at least 30 variables in the multivariate

analysis [13]. Based on an average inclusion of 4 patients per centre per month, we

calculated that 63 centres are mandatory to include 1500 patients in 6 months.



5. METHODS5.1 Study endpoints5.1.1 Primary study endpointThe primary endpoint is to determine the incidence of extubation failure in severe

brain-injured patients according to international recommendations [3]. We will also

evaluate the incidence of extubation failure according to recently proposed new

definitions of extubation failure [11, 14, 15].

5.1.2 Secondary study endpointsThe secondary endpoints are to evaluate:

- the incidence of delayed extubation

- the causes of extubation failure according to different timings of re-intubation (48

hours, 96 hours, > 96 hours)

- the validation of a clinical score compatible with successful extubation

- the incidence of tracheostomy

- the management of tracheostomy

- the consequences of extubation failure, weaning, delayed extubation and

tracheostomy on the outcome: ventilator acquired pneumonia (VAP),

tracheobronchitis, duration of MV, ICU length of stay, in ICU-mortality, in-hospital

mortality.

5.2 RandomizationNot applicable

5.3 Study proceduresInclusion will be performed over a 6 months’ period, starting the 1st of the initial month

and finishing at the end of the 6th month.

Time points of data collection:

-Demographic and baseline data are collected from the clinical files from the day of

ICU admission to the day of extubation/tracheostomy

-Respiratory settings like MV parameters and PaO2, PCO2 will be recorded at day1,

day 3 and day 7

-Neurological events during the ICU course

-Description of the weaning process

-Standardized physical examination on the day of extubation/tracheostomy



-In-ICU events: VAP, length of mechanical ventilation, ICU length of stay (LOS)

-In-hospital mortality

5.4 Data collectionData are collected in an electronical Case Report Form (CRF). Local investigators

are expected to transcribe all collected data in an internet-based e-CRF. Access to

the data is managed by the ESICM. Local investigators are expected to transcribe all

collected data on the e-CRF. The data to be completed are available in the CRF

(page 19). All definitions regarding the different items are listed in the Appendices list

(page 34).

5. 5 Withdrawal of individual subjectsThis is a strictly observational study, using data for epidemiological analyses. In this

context, the patient’s consent to participate will be waived. The patient or next-of-kin

will receive information. In case the patient or next-of-kin refuses to participate, the

patient’s data will be destroyed.



6. STATISTICAL ANALYSISThe data to be collected are all part of the routine clinical care. Patient characteristics

are compared and described by appropriate statistics.Student’s t-test or Mann-

Whitney U-tests are used to compare continuous variables and chi-squared tests are

used for categorical variables. Data are expressed as means (SD), medians

(interquartile range) and proportions as appropriate. Comparison between and within

groups are performed using one-way ANOVA and post-hoc analyses for continuous

variables. To identify potential factors associated extubation failure univariate

analyses are performed. In case of inconsistent event/number of co-variates ratio, a

LASSO (Least Absolute Shrinkage Selection Operator) selection of variables will be

realised [16]. Multivariate logistic regression model is used to identify independent

risk factors for extubation success [13]. A stepwise approach is used to enter new

terms into the model, with a limit of p<0.05 to enter the terms. Time to event variables

are analysed using Cox regression and visualized by Kaplan-Meier. Statistical

significance is at a p–value of <0.05. Where appropriate statistical uncertainty is

expressed by 95% confidence levels.



7. ETHICAL CONSIDERATIONS7.1 Regulation statementThe study will be conducted according to the principles of the Declaration of Helsinki

(version of 2008) and in accordance with the Medical Research Involving Human

Subjects Act (WMO) [17]. Data management, monitoring and reporting of the study

will be performed in accordance with the ICH-GCP Guidelines [18].

7.2 Ethical and Regulatory authorities’ approval

All participating centres must submit the study to their local or national IRB/IEC for

ethical judgement and obtain a document of proof that the study has been subject to

IRB/IEC review and given approval opinion. Considering that all study data are part

of routine practice ethical approval may not be required in some centres. However,

where ethical approval is required, this approval must be obtained before the start of

inclusion. If authorization/approval/notification by the regulatory authority(ies) is

applicable locally, this document should be obtained prior to initiation of the trial in

compliance with the applicable regulatory requirement(s). In France, we will ask the

IRB for a nationwide ethical statement.

7.3 Patient Information and Informed consent

This is a strictly observational study. Therefore, informed consent is not mandatory

for participation. Patient, as soon as neurological recovery is appropriate, and next-

of-kin, during ICU course will receive oral and written information regarding

participation. Each national IRB/IEC should provide approval/favourable opinion

before the beginning of inclusions in each country. The information form will be

modified according to local regulations, to make each IRB/IEC free in the decisions

and organizations.

The study coordinator provides a template of Patient Information Sheet in English

(see Appendices list, pages from 37 to 42).



8 ADMINISTRATIVE ASPECTS AND PUBLICATION

8.1 Handling and storage of data and documents

To facilitate patient follow-up a paper CRF is provided with a cover page (confidential

patient identification form). Data collected will be anonymized. No patient names,

patient initials or hospital patient numbers are kept on the paper CRF or collected

electronically, according to French, to allow circulation of medical data around the

world on the web. After completing follow-up, the paper CRF should be stored in the

secured place. The paper CRF’s should be stored behind a lock at the local site.

Data will be handled confidentially and centres should keep all data stored for the

length of the study and the time foreseen by local rules, but at least for a period of 10

years from the moment of the study completion. Each centre will maintain an

Investigator File including: protocol, IRB judgment, E.C. approval (if applicable), local

investigator delegation log, local translation of information form, etc. All handling of

personal data will comply with the GCP–guidelines [18].

8.2 Public disclosure and publication policy

The protocol of the ENIO study will be submitted to the BMJ Open journal. On

behalf of the Steering Committee, the ESICM will act as custodian of the data. The

ESICM and the Steering Committee holds the right to use all pooled data for

scientific and other purposes. The results of this study will be published in a peer–

reviewed medical journal. After publication of the primary results, on request the

pooled dataset will be available for all members of the ENIO collaboration for

secondary analysis, after judgment and approval of scientific quality and validity of

the proposed analysis by the Steering Committee. Before submission the final

version of all manuscripts related to the ENIO dataset, must be approved by the

Steering Committee.

The authorship ground rules are as follows. The statistician and the head investigator

will automatically be mentioned. The head investigator will be mentioned as the first

author in the primary results publication. All investigators will be cited in Pubmed

according to the following rule: National coordinator will be in the subheading of the



main paper and two investigators per centre will be cited in the ENIO study group.

The order of authors for national coordinators will be according to the number of

patients included during the study period. Investigators in the ENIO study group will

appear in alphabetical order.

All proposals for sub-studies on the main ENIO database are encouraged. Secondary studies must be approved by the steering committee. Study results will be presented and disseminated in a timely manner. Authorship will be proposed by the investigators of the sub-studies and approved by the steering committee. National groups may enter requests for data-access to analyse their national datasets. Owing to the full anonymization of data according to European Union laws and regulations, institutional datasets will not be available.

8.3 Organization

National coordinators will be appointed in each participating country if needed. They

will identify and recruit local participating centres. They will assist and train the local

coordinator and monitor the conduction of the study according to ICH-GCP

guidelines [18]. They will ensure that all local necessary ethical and regulatory

approvals are obtained before start of patient inclusion. They will assist and validate

translation of study documents (protocol, CRF, patient and next-of-kin information

sheet) and help coordinating data cleaning in their countries if needed.

Local coordinators in individual participating centres will provide scientific and

structural leadership in their centre. They will ensure all local necessary ethical and

regulatory approvals are obtained before start of patient inclusion. They will train and

monitor their local research group, to ensure the study is conducted according to

ICH-GCP guidelines [18]. They guarantee the integrity of data collection and ensure

timely completion of CRF’s.



9. REFERENCES

1. Rosenfeld JV, Maas AI, Bragge P, et al (2012) Early management of severe traumatic brain injury. Lancet 380:1088–1098. doi: 10.1016/S0140-6736(12)60864-2

2. Pelosi P, Ferguson ND, Frutos-Vivar F, et al (2011) Management and outcome of mechanically ventilated neurologic patients*. Crit Care Med 39:1482–1492. doi: 10.1097/CCM.0b013e31821209a8

3. Boles J-M, Bion J, Connors A, et al (2007) Weaning from mechanical ventilation. European Respiratory Journal 29:1033–1056. doi: 10.1183/09031936.00010206

4. Navalesi P, Frigerio P, Moretti MP, et al (2008) Rate of reintubation in mechanically ventilated neurosurgical and neurologic patients: Evaluation of a systematic approach to weaning and extubation. Crit Care Med 36:2986–2992. doi: 10.1097/CCM.0b013e31818b35f2

5. Namen AM, Ely EW, Tatter SB, et al (2001) Predictors of successful extubation in neurosurgical patients. Am J Respir Crit Care Med 163:658–664. doi: 10.1164/ajrccm.163.3.2003060

6. Coplin WM, Pierson DJ, Cooley KD, et al (2000) Implications of extubation delay in brain-injured patients meeting standard weaning criteria. Am J Respir Crit Care Med 161:1530–1536.

7. Salam A, Tilluckdharry L, Amoateng-Adjepong Y, Manthous CA (2004) Neurologic status, cough, secretions and extubation outcomes. Intensive Care Medicine 30:1334–1339. doi: 10.1007/s00134-004-2231-7

8. Karanjia N, Nordquist D, Stevens R, Nyquist P (2011) A Clinical Description of Extubation Failure in Patients with Primary Brain Injury. Neurocrit Care 15:4–12. doi: 10.1007/s12028-011-9528-5

9. Alali AS, Scales DC, Fowler RA, et al (2014) Tracheostomy timing in traumatic brain injury. Journal of Trauma and Acute Care Surgery 76:70–78. doi: 10.1097/TA.0b013e3182a8fd6a

10. Lazaridis C, DeSantis SM, McLawhorn M, Krishna V (2012) Liberation of neurosurgical patients from mechanical ventilation and tracheostomy in neurocritical care. J Crit Care 27:417.e1–417.e8. doi: 10.1016/j.jcrc.2011.08.018

11. Thille AW, Boissier F, Ben Ghezala H, et al (2015) Risk Factors for and Prediction by Caregivers of Extubation Failure in ICU Patients. Crit Care Med 43:613–620. doi: 10.1097/CCM.0000000000000748

12. Asehnoune K, Seguin P, Lasocki S, et al (2017) Extubation success prediction in a multi-centric cohort of patients with severe brain-injury. Anesthesiology in press



13. Harell FE Regression Modeling Strategies., 2001st ed. Springer Verlag

14. Miltiades AN, Gershengorn HB, Hua M, et al (2017) Cumulative Probability and Time to Reintubation in U.S. ICUs. Crit Care Med 45:835–842. doi: 10.1097/CCM.0000000000002327

15. Ruan S-Y, Teng N-C, Wu H-D, et al (2017) Durability of Weaning Success for Liberation from Invasive Mechanical Ventilation: An Analysis of a Nationwide Database. Am J Respir Crit Care Med rccm.201610–2153LE. doi: 10.1164/rccm.201610-2153LE

16. Kaukonen K-M, Bailey M, Pilcher D, et al (2015) Systemic Inflammatory Response Syndrome Criteria in Defining Severe Sepsis. N Engl J Med 150319144911000. doi: 10.1056/NEJMoa1415236

17. General Assembly of the World Medical Association (2014) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent 81:14–18.

18. EMEA Guideline for Good Clinical Practice E6(R1).

19. Brain Trauma Foundation, American Association of Neurological Surgeons, Congress of Neurological Surgeons (2007) Guidelines for the management of severe traumatic brain injury. J Neurotrauma 24 Suppl 1:S1–106. doi: 10.1089/neu.2007.9999

20. Connolly ES, Rabinstein AA, Carhuapoma JR, et al (2012) Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 43:1711–1737. doi: 10.1161/STR.0b013e3182587839

21. Stocchetti N, Maas AIR (2014) Traumatic Intracranial Hypertension. N Engl J Med 370:2121–2130. doi: 10.1056/NEJMra1208708

22. Teasdale G, Jennett B (1974) Assessment of coma and impaired consciousness. A practical scale. Lancet 2:81–84.

23. Jennett B, Bond M (1975) Assessment of outcome after severe brain damage. The Lancet 1:480–484.

24. Needham DM, Yang T, Dinglas VD, et al (2015) Timing of Low Tidal Volume Ventilation and Intensive Care Unit Mortality in Acute Respiratory Distress Syndrome. A Prospective Cohort Study. Am J Respir Crit Care Med 191:177–185. doi: 10.1164/rccm.201409-1598OC

25. Jaber S, Chanques G, Matecki S, et al (2003) Post-extubation stridor in intensive care unit patients. Risk factors evaluation and importance of the cuff-leak test. Intensive Care Medicine 29:69–74. doi: 10.1007/s00134-002-1563-4

26. Maury E, Guglielminotti J, Alzieu M, et al (2004) How to identify patients with no risk for postextubation stridor? J Crit Care 19:23–28.



27. American Thoracic Society, Infectious Diseases Society of America (2005) Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 171:388–416. doi: 10.1164/rccm.200405-644ST



10. CASE REPORT FORM

Number of patient: /_________/

Date of ICU admission = Day 1 /__/__/____/ (DD/MM/YYYY)

Inclusion criteria - Age ≥ 18 years’ old

- Patients admitted in a ICU for a central neurological pathology, listed as follows,

with estimated or clinically evaluated Glasgow Coma Score ≤12 before endo-

tracheal intubation, with anomaly on brain CT-scan and requiring invasive

mechanical ventilation ≥ 24 hours are eligible to the study:

Traumatic Brain Injury

Aneurysmal Subarachnoid haemorrhage

Intra-Cranial Haemorrhage

Ischemic Stroke

Central Nervous System Infection (Abscess, Empyema, Meningitides,

Encephalitis…)

Brain Tumour

- Patient with an attempt of extubation and/or tracheostomy performance

Exclusion criteria - Patients < 18 years old

- Patients with ongoing pregnancy

- Patients with spine cord injury above T4

- Resuscitated cardiac arrest

- Withdrawal of Life-Sustaining Treatment (WLST) in the first 24 hours

NB: All data should be completed. When datum is not available, please fill out “NA”



DEMOGRAPHIC DATA AT ICU ADMISSION

Age:

Gender: Male/Female

Height (cm): Measured Body Weight (kg): Origin of Brain Injury chose item among:

Traumatic Brain Injury (yes/no)

Aneurysmal subarachnoid haemorrhage (yes/no)

Intra-cranial haemorrhage (yes/no)

Ischemic Stroke (yes/no)

Central Nervous System Infection (yes/no)

Brain tumour (yes/no)

Other (yes/no)

Lowest Glasgow Coma Score before endo-tracheal intubation Eyes = Choose item among (1-none, 2-opens to pain, 3-opens to voice, 4-

opens spontaneously)

Verbal = Choose item among (1-none, 2-incomprehensible sounds, 3-words,

incoherent, 4-disoriented conversation 5-normal conversation)

Motor = Choose item among (1-none, 2-decerebrate posturing, 3-decorticate

posturing, 4-withdraws from pain, 5-localizes pain, 6- normal)

Total = (Automatic calculation Y+M+V)

Episode of Anisocoria in the first 24 hours (of neurologic origin ie

exclusion of ophthalmologic causes) (yes/no)

Medical History Choose items among

Chronic obstructive pulmonary disease (yes/no)

Chronic heart failure (NYHA > 2) (yes/no)

Chronic hypertension (yes/no)

Active smoking (yes/no)



Diabetes (yes/no)

History of malignancy in the previous 5 years (yes/no)

NEURO-SURGICAL MANAGEMENT DURING ICU

Intra-cranial probe for ICP monitoring: yes/no

External ventricular drainage: yes/no

Posterior fossa injury: yes/no

Therapeutic hypothermia: yes/no

Barbiturate coma (≥ 1day duration): yes/no

Neuro-surgery (evacuation of extra or sub-dural hematoma, intra-cranial hematoma evacuation, lobectomy…): yes/no

Decompressive craniectomy: yes/no



INITIAL VENTILATORY MANAGEMENT

First day of ICU admission closest from 8:00 AMVentilatory support mode (choose among): Volume Assisted Mode / Pressure

Controlled Mode / Pressure Assist Mode

Tidal Volume (mL): /____/

PEEP (cmH2O): /____/

Respiratory rate (/mn): /____/

Plateau pressure (cmH2O): /____/

PaO2 (mmHg): /____/

PCO2 (mmHg): /____/

FiO2 (%): /____/

pH: /____/

Day 3 after ICU admission at 8:00 AMVentilatory support mode (choose among): Volume Assisted Mode / Pressure

Controlled Mode / Pressure Assist Mode / Spontaneous Breathing

Tidal Volume (mL) (NA if applicable): /____/

PEEP (cmH2O) (NA if applicable): /____/


Plateau pressure (cmH2O) (NA if applicable): /____/

PaO2 (mmHg) (NA if available): /____/

PCO2 (mmHg) (NA if available): /____/

FiO2 (%) (NA if applicable): /____/

pH (NA if available): /____/

Day 7 after ICU admission at 8:00 AM Ventilatory support mode (choose among): Volume Assisted Mode / Pressure

Controlled Mode / Pressure Assist Mode / Spontaneous Breathing

Tidal Volume (mL) (NA if applicable): /____/

PEEP (cmH2O) (NA if applicable): /____/




Plateau pressure (cmH2O) (NA if applicable): /____/

PaO2 (mmHg) (NA if available): /____/

PCO2 (mmHg) (NA if available): /____/

FiO2 (%) (NA if applicable): /____/

pH (NA if available): /____/

INITIAL SEDATION and ANALGESIA MANAGEMENT

First day of ICU admission closest from 8:00 AMMidazolam yes/no

Propofol yes/no

Dexmedetomidine yes/no

Pentothal yes/no

Neuro-muscular blockers yes/no

Day 3 after ICU admission at 8:00 AM

Midazolam yes/no

Propofol yes/no


Pentothal yes/no


Day 7 after ICU admission at 8:00 AMMidazolam yes/no

Propofol yes/no


Pentothal yes/no


Day of continuous intra-venous hypnotic drug discontinuation. Calendar View



MANAGEMENT OF EXTUBATION

Date of first spontaneous breathing trial completion (Defined as

successful spontaneous breathing on T-Tube or spontaneous ventilation with

7-8 cm H2O during at least 30 minutes): Calendar view

Extubation during ICU: yes/no. If no, all other items from “Management

of extubation” and “Data the day of extubation” are NA and please skip to “Did

the patient require tracheostomy”

Discontinuation of enteral nutrition support of at least 6 hours before extubation attempt: yes/no

Cuff leak test performance: yes/no

Corticosteroids to prevent post-extubation stridor before extubation: yes/no

DATA THE DAY OF EXTUBATION

Date of first extubation: Calendar view

Spontaneous Breathing TrialT-piece: yes/no. If yes duration in the 6 hours before extubation (mn): /____/

In case of SBT on T-piece:

SpO2 (%) at the end of SBT: /____/

Respiratory rate(/mn): /____/

Systolic Arterial Pressure (mmHg): /____/

CPAP: yes/no. If yes duration in the 6 hours before extubation (mn): /____/

Positive Pressure with 7-8 cm H2O during at least 30 minutes: yes/no. If yes duration

in the previous 4 hours (mn): /____/

Type of extubation: planned/accidental

General data at 8:00 AM the day of extubation: Measured Body Weight (kg) the day of extubation attempt: /____/

Temperature the day of extubation (choose among Celsius/Farenheit): /____/

Tidal Volume (mL): /____/



PEEP (cmH2O): /____/

SpO2 (%): /____/

Systolic Arterial Pressure (mmHg): /____/


Heart rate (/mn): /____/

Before extubation, Visual pursuit: yes/no

Defined as the patient’s ability to follow a staff member in the room, a moving item in front of the

patient’s face or a transient stimulus

Before extubation, Swallowing attempts: yes/no

Defined as pharyngo-laryngeal efforts along with thyroid cartilage movements compatible with

swallowing attempts

Before extubation, Gag reflex: Choose item among:

Present/Absent/Not done

Before extubation, Endo-tracheal aspirates frequency (in the

hour before extubation): Choose item among: >3 times per hour/2-3 times

per hour /1-2 times per hour / less than one per hour / Not done

Before extubation, Cough: Choose item among:

Vigorous/Moderate/Weak/None

Before extubation, Glasgow Coma score in intubated patient: E = Choose item among (1-none, 2-opens to pain, 3-opens to voice, 4-opens

spontaneously)

V = Choose item among (1-patient not trying to speak, 4- if physicians evaluates that

the patients tries to speak in spite of endo-tracheal tube)

M = Choose item among (1-none, 2-decerebrate posturing, 3-decorticate posturing,

4-withdraws from pain, 5-localizes pain, 6- normal)

Total = (Automatic calculation Y+M+V)

Physiotherapy in the 24 hours following extubation: yes/no

If yes: Prophylactic/Curative



ASSESSMENT OF EXTUBATION SUCCESS

Did the patient need re-intubation: yes/no. If no, items regarding

“Date of re-intubation” and “Reasons of re-intubation” are NA

Date of re-intubation Calendar view

Reason of re-intubation Neurological impairment yes/no

Respiratory failure yes/no

Airway failure yes/no

Cardiac failure yes/no

Surgery yes/no

Other yes/no

DID THE PATIENT REQUIRE TRACHEOSTOMY?

DATA THE DAY OF TRACHEOSTOMY

Tracheostomy during ICU: yes/no. If no, all other items from “Data the

day of tracheostomy” and “Management of tracheostomy” are NA

Date of tracheostomy Calendar view

Reason for tracheostomy Expected long duration of mechanical ventilation because of severe

neurological damages yes/no

Extubation failure yes/no

Neurologic impairment yes/no

Airway failure yes/no

Severe face and/or neck trauma yes/no

Chronic respiratory disease yes/no

Other yes/no



IN-ICU EVENTS AND OUTCOME

Episode of nosocomial VAP during ICU course: yes/no

Episode of nosocomial VAP after first day of first SBT completion: yes/no

Episode of tracheo-bronchitis after first day of first spontaneous breathing trial completion: yes/no

Episode of ARDS during ICU course (Berlin definition): yes/no

If yes, choose among: mild/moderate/severe

Invasive MV duration:Day of start (calendar view)

Day of end (calendar view)

Non-invasive MV duration:Day of start (calendar view)


Prophylactic Non-invasive MV: yes/no

Curative Non-invasive MV: yes/no

Cumulative high flow oxygen nasal cannula duration:Day of start (calendar view)


Prophylactic Non-invasive MV: yes/no

Curative Non-invasive MV: yes/no

Date of ICU discharge: Calendar view

Decision of Withdrawal of Life-Sustaining Treatment during ICU: yes/no. If yes, date of Withdrawal of Life-Sustaining Treatment (calendar

view)

In-ICU mortality: yes/no

In-hospital mortality: yes/no



11. APPENDICES LISTAppendix 1. Bundle of neurologic, respiratory and weaning managementAppendix 2. Glasgow Coma Score,Appendix 3. DefinitionsAppendix 4. Patient’s information sheet (in English)Appendix 5. Next-of-kin information sheet (in English)



Appendix 1. Bundle of neurologic, respiratory and weaning management Neurologic management:

Initial management of brain-injury will be specific to the initial pathology (trauma,

subarachnoid haemorrhage, intra-cranial bleeding…) and according to international

guidelines [19-21]. Sedation will be stopped as soon as intra-cranial pressure control

is deemed appropriate, according to neurologic monitoring, brain scans and local

protocols. Neurological monitoring will be performed according to each centres’ local

protocols (microdialysis, PtiO2, electroencephalogram, etc…). No specific

neuromonitoring is required for the study.

Respiratory management:

All centres are committed to:

1) perform endo-tracheal tube cuff monitoring a least 3 times a day.

2) follow weaning protocols of the international guidelines [3]. Patients are checked

for extubation when they had successful spontaneous breathing trial is fulfilled,

defined as breathing on T-Tube or spontaneous ventilation with 7-8 cm H20 during at

least 30 minutes. Criteria of successful spontaneous breathing trial are: 1) stable

cardio-vascular status (heart rate 140 beats.min-1, systolic blood pressure 90-

160mmHg, minimal or absence of catecholamine, 2) adequate oxygenation (SpO2

90%, FiO2 40%, PEEP 8 cmH2O, respiratory rate 35 breaths.min-1), 3) PaCO2

50mmHg, 4) core temperature < 38.5°C, 5) pH 7.35.

3) Maximal inspiratory pressure, maximal expiratory pressures, and maximal

expiratory flow monitoring are not recommended before extubation.



Appendix 2. Glasgow Coma Score [22]

Eye Opening ResponseSpontaneous-open with blinking at baseline. 4 pointsTo verbal Stimuli, command, speech. 3 pointsTo pain only (not applied to face). 2 pointsNo response. 1 point

Verbal ResponseOriented. 5 pointsConfused conversation but able to answer questions. 4 pointsInappropriate words. 3 pointsIncomprehensible speech. 2 pointsNo response. 1point

Motor ResponseObeys commands for movement. 6 pointsPurposeful movement to painful stimulus. 5 pointsWithdraws in response to pain. 4 pointsFlexion in response to pain (decorticate posturing). 3 pointsExtension response in response to pain (decerebrate posturing). 2 pointsNo response. 1point



Appendix 3. Definitions

Cuff leak test performanceThe realization of a cuff leak test is not mandatory for the need of the study. Each

centre will perform the cuff leak test according to local protocols and to previously

published article. For example:

ventilator in assist-control mode with the tidal volume (VT) set at 10–12 ml/kg.

An initial measurement of inspiratory VT was achieved with the cuff inflated.

Then, the cuff was deflated and after the elimination of artefacts due to cough,

four to six consecutive breaths were used to compute average values for the

expiratory VT. The leak was calculated as the difference between the

expiratory VT with the cuff inflated and the expiratory VT with the cuff deflated.

[25]

In spontaneously breathing patients, immediately before extubation, the

tracheal tube is deflated and the absence of cough is monitored. The tube was

then obstructed with a finger, and the absence of leak is monitored. [26]

Visual pursuit [12]: defined as the ability to follow a staff member in the room

or a moving item in front of the patient’s face

Swallowing attempts [12]: defined as pharyngo-laryngeal efforts along with

thyroid cartilage movements compatible with swallowing attempts

Endo-tracheal aspirates frequency (in the hour before extubation) [6]: Defined as the frequency of endo-tracheal aspirations performed by medical

and/or para-medical staff in the hour before extubation

More than 3 times

Between 2 and 3 times

Between 1 and 2 times

Less than 1 time

Cough:



Vigorous. Defined as the patient’s ability to cough sputum out of the endo-

tracheal tube

Moderate. Defined as the patient’s inability to cough sputum out of the endo-

tracheal tube

Weak. Defined as movements of cough without mobilisation of sputum in the

endo-tracheal tube

Ventilator Acquired Pneumonia and tracheobronchitis. Defined with the

ATS criteria [27]. Diagnosis is suspected when patient has a radiographic

infiltrate that is new or progressive, along with clinical findings suggesting

infection, which include the new onset of fever, purulent sputum, leukocytosis,

and decline in oxygenation. When fever, leukocytosis, purulent sputum, and a

positive culture of a sputum or tracheal aspirate are present without a new

lung infiltrate, the diagnosis of nosocomial tracheobronchitis should be

considered.

Neurological impairment after extubation Defined as a Glasgow coma score ≤ 8 or a significant decrease in the

Glasgow coma score

Respiratory failure yes/no [3]

Clinical signs of respiratory muscle fatigue or increased work of breathing

Respiratory rate > 25 breaths.min-1 for 2 h

SaO2 < 90%, PaO2 < 80 mmHg on FiO2 ≥ 0.50,Hypercapnia (PaCO2 > 45 mmHg or ≥ 20% from pre-extubation), pH<7.33

Airway failure

Defined as post-extubation stridor needing re-intibation [25]

Or significant neck/face/otorhinolaryngology trauma/impairment rendering

extubation illusionary

Cardiac failure [3]



Heart rate ≥ 140 beats.min-1 or sustained increase or decrease of >20%



Appendix 4. Patient information sheet

The ENIO studyExtubation strategies in the Neuro-Intensive

unit patient and associations with the OutcomePatient informed sheet.

Dear Sir or Madam:You are invited to participate in an international collaboration research study endorsed by the Neuro-Intensive Care section of the European Society of Intensive Care Medicine. Before deciding whether or not to take part in this study, we would ask you to carefully read the following information which explains the study’s objectives and the implications of your possible participation.

Study objective The main objective is to investigate the management of extubation and/or tracheostomy in the following of a brain injury (traumatism, intra-cerebral haemorrhage, subarachnoid haemorrhage, etc…).

Study description The investigator in your centre will collect information from your medical charts concerning previous illnesses, the events during your intensive care unit course and the data regarding the management of extubation and/or tracheostomy if applicable. During the intensive care unit course, the investigator will collect the data.

What does your participation involve? Whether you decide to participate or not will not affect the medical care you are going to receive. If you decide not to take part in this study, it will not alter your treatment. The treating doctors will not modify their decisions, neither during your hospital stay nor after your discharge, because you have participated or not. No extra biological samples will be performed for the need of the study. No extra medical examination will be performed.

Withdrawal from the study Even though you have agreed to participate you may leave the study whenever you wish and, moreover, without having to offer any kind of explanation. You will not have to justify your decision.



Privacy and use of clinical information In order to carry out the study it will be necessary to consult and make use of some of the information that appears in your medical record. Your acceptance will authorize us to consult and process the information in the following manner: - Information will be stored in a computerized database for all the participants - All information will be stored and anonymized. All clinical information that is obtained for the study will be identified by a number. No data concerning personal identification will bestored in the database.

Results of the research study The results obtained in the present study will be published in a major medical journal. In the article, all participating centres will be listed and all investigators will have a copy. Finally, we would like to draw your attention to the fact that this informative consent document refers only to your participation in this study.

Any inquiries concerning the study should be addressed to: Hospital researcher: ___________________________________________Telephone: ________ Field work coordinator:___________________________________________Telephone: ________ If you have any questions related to your rights as a participant in the study you can get in touch with (Hospital Ethics Committee contact): ______________ _____________________________Telephone: ________

Thank you for taking time to read this information sheet.



Appendix 5 – Next-of-kin Information sheet

The ENIO studyExtubation strategies in the Neuro-Intensive

unit patient and associations with the OutcomeNext-of-kin informed sheet.

Dear Sir or Madam:Your relative is invited to participate in an international collaboration research, endorsed by the Neuro-Intensive Care section of the European Society of Intensive Care Medicine.Before deciding whether or not he/she should take part in this study, we would ask you to carefully read the following information which explains the study’s objectives and the implications of his/her possible participation.

Study objective The main objective is to investigate the management of extubation and/or tracheostomy in the following of a brain injury (traumatism, intra-cerebral haemorrhage, subarachnoid haemorrhage, etc…).

Study description The investigator in your centre will collect information from his/her medical charts concerning previous illnesses, the events during the intensive care unit course and the data regarding the management of extubation and/or tracheostomy if applicable. During the intensive care unit course, the investigator will collect the data.

What does the participation involve? Whether you agree for your relative that he/she participates or not will not affect the medical care he/she will receive. If you decide that your relative will not take part in this study, it will not alter his/her the treatment. The treating doctors will not modify their decisions, neither during the hospital stay nor after discharge, because you relative have participated or not. No extra biological samples will be performed for the need of the study. No extra medical examination will be performed.

Withdrawal from the study Even though you have agreed that your relative participates, he/she may leave the study whenever you wish and, moreover, without having to offer any kind of



explanation. You will not have to justify your decision.

Privacy and use of clinical information In order to carry out the study it will be necessary to consult and make use of some of the information that appears in the medical record. Your acceptance will authorize us to consult and process the information in the following manner: - Information will be stored in a computerized database for all the participants - All information will be stored and anonymized. All clinical information that is obtained for the study will be identified by a number. No data concerning personal identification will bestored in the database.

Results of the research study The results obtained in the present study will be published in a major medical journal. In the article all participating centres will be listed and all investigators will have a copy. Finally, we would like to draw your attention to the fact that this informative consent document refers only to your relative’s participation in this study.

Any inquiries concerning the study should be addressed to: Hospital researcher: ___________________________________________Telephone: ________ Field work coordinator:___________________________________________Telephone: ________ If you have any questions related to your rights as a participant in the study you can get in touch with (Hospital Ethics Committee contact): ______________ _____________________________Telephone: ________

Thank you for taking time to read this information sheet.


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