Determinants of Successful Tracheostomy Removal in Difficult-to-wean Patients: A Prospective Cohort Study
Phase: NA
Conditions: Tracheostomy, ICU, Weaning Failure
Sponsor: Hopital Forcilles

DESCATRON V3.0 du 14/01/2021 
 
STUDY OF THE DETERMINANTS OF THE SUCCESS OF 
DECANULATION IN TRACHEOTOMY PATIENTS IN THE DIFFICULT-
TO-WEAN UNIT. A COHORT STUDY 
 
ACRONYM: DESCATRON 
 
Version n°3 of 14/01/2021 
 
Protocol 
number 
N° ID RCB1 
N° CPP 
N° CNIL ou MR 
N° Clinical Trial 
2020-11-1 
2020-A03070-39 
20.11.24.63318 
RIPH2 HPS 
MR-001 
<…> 
 
 
INVESTIGATEUR PRINCIPAL 
Dr Jean-Baptiste PERETOUT, médecin réanimateur 
Unité de Soins Intensifs Respiratoire et de Réadaptation Post-Réanimation 
Hôpital Forcilles - Fondation Cognacq Jay 
Route de Servon 
77150 Férolles-Attilly 
Tél : 01 60 64 60 39 / Mail : jperetout@cognacq-jay.fr 
SUB-INVESTIGATORS 
Dr Gérald CHOUKROUN, médecin réanimateur, chef de service 
Unité de Soins Intensifs Respiratoire et de Réadaptation Post-Réanimation 
Hôpital Forcilles - Fondation Cognacq Jay 
Tél : 01 60 64 60 39 / Mail : gchoukroun@cognacq-jay.fr 
METHODOLOGY 
Dr Arthur SPILLEBOUT, médecin santé publique 
Département Informatique Médicale 
Hôpital Forcilles - Fondation Cognacq Jay 
 
 
Promotor : 
Hôpital Forcilles-Fondation Cognacq-Jay 
Route de Servon 77150 Férolles-Attilly 
Contact : 
Aymeric LE NEINDRE 
aleneindre@cognacq-jay.fr  
Tél: 01 60 64 61 31 
 
 
                                               
 

DESCATRON V3.0 du 14/01/2021 
 
 
 
KEY CONTACTS 
SURNAME, NAME 
ROLE 
FUNCTION 
COORDONNEES 
Dr Jean-Baptiste 
PERETOUT 
Investigateur 
principal 
Médecin 
réanimateur 
Hôpital Forcilles - Fondation Cognacq 
Jay 
USIR-SRPR 
jperetout@cognacq-jay.fr 
Tel. : 01 60 64 60 39 
Dr Gérald CHOUKROUN 
Investigateur 
secondaire 
Médecin 
réanimateur, chef 
de service 
Hôpital Forcilles - Fondation Cognacq 
Jay 
USIR-SRPR 
gchoukroun@cognacq-jay.fr 
Tél : 01 60 64 60 39 
Aymeric LE NEINDRE 
Coordonnateur 
de Recherche 
Clinique 
Docteur en science 
Hôpital Forcilles 
Commission de Recherche Clinique 
aleneindre@cognacq-jay.fr  
Tel. : 01 60 64 61 31 
Dr Arthur SPILLEBOUT 
Méthodologie 
Médecin santé 
publique 
Hôpital Forcilles 
Département d’Informatique Médicale 
spillebout@cognacq-jay.fr  

DESCATRON V3.0 du 14/01/2021 
PROTOCOL VERSION HISTORY 
 
 
Version 
Date 
Reasons 
2 
15/12/2020 
Avis du CPP 
3 
14/01/2021 
Avis du CPP 
 
 
 
 
 
 

DESCATRON V3.0 du 14/01/2021 
SUMMARY OF THE RESEARCH 
 
Manager 
Forcilles Hospital-Cognacq-Jay Foundation 
Person who 
directs and 
monitors the 
research 
PERETOUT Jean-Baptiste 
Title 
Study of the determinants of successful decanulation in tracheostomized patients 
in the post-intensive care unit. A cohort study 
Acronym 
DESCATRON 
Protocol version 
n° of 14/01/2021 
Rationale / 
context 
The success factors for decanulation are not well known in the literature and the 
decision to decanulate is mainly based on clinical judgment. 
The failure rate of decanulation is between 2 and 25% with a poor prognosis in 
case of failure. 
Main Objective 
To determine the factors associated with successful decanulation in 
tracheostomised patients admitted to Difficult-to-Wean Unit. 
Secondary 
objectives 
The secondary objectives are to evaluate in tracheostomized patients 
hospitalized in Difficult-to-Wean Unit.: 
-The prevalence of successful decanulation ; 
-The prevalence of successful weaning from invasive ventilation; 
-Factors associated with successful weaning from invasive ventilation (VI); 
-Demographic characteristics of these patients at admission; 
-The ventilatory characteristics of these patients at admission; 
-Biological characteristics of these patients at admission; 
Research scheme 
Prospective, monocentric, interventional cohort study with minimal risks and 
constraints falling under 2° of article L.1121-1 of the Public Health Code. 
Inclusion criteria 
-Admission to Difficult-to-Wean Unit at Forcilles Hospital; 
-Presence of a tracheotomy on admission to DIFFICULT-TO-WEAN UNIT; 
-Presence of invasive ventilation on admission to DIFFICULT-TO-WEAN UNIT 
with a predicted duration of > 48 hours; 
-Patient aged at least 18 years at the time of inclusion; 
-Affiliation to or beneficiary of a social security scheme; 
-Oral, free, informed and express consent of the patient or a relative. 
Non-inclusion 
criteria 
-Known pregnancy ; 
-Person subject to a legal protection measure; 
-Person under guardianship or curatorship; 
-Refusal of access to data by the patient or the designated trusted person. 
Primary endpoint 
Factors potentially associated with successful decanulation will be collected 
prospectively: 
-Severity factors related to the ICU stay; 

DESCATRON V3.0 du 14/01/2021 
-Ventilatory factors; 
-Respiratory factors; 
-Extra-respiratory factors; 
Secondary 
evaluation criteria 
-Proportion of successful decanulation among all included patients; 
-Proportion of successful weaning from IV among all included patients; 
-Collection of biological parameters within the first 48 hours of admission to 
DIFFICULT-TO-WEAN UNIT; 
-Ventilatory parameters on admission to DIFFICULT-TO-WEAN UNIT; 
-Demographic characteristics of these patients during DIFFICULT-TO-WEAN 
UNIT hospitalisation: mortality, duration of hospitalisation, duration of invasive 
ventilation. 
-Nutritional status. 
Comparison 
groups 
None 
Number of 
subjects needed 
100 
Expected number 
of centres 
1 
Duration of the 
research 
25 months 
Statistical 
analysis of data 
Univariate comparisons will use the usual statistical tests after verification of the 
distribution of the variables (Chi2 or Fisher's test, t-test, anova or their non-
parametric equivalents Wilcoxon and Kruskal-Wallis tests). The variables will be 
compared between the 2 groups (failure or success of decanulation) by the 
appropriate tests according to the type of variables (quantitative or qualitative) 
and their distribution. The selection of variables in the prediction model will be 
done by multivariate logistic regression based on AIC. 
Expected benefits 
Useful information for post-ICU settings follow-up and for prioritising or not early 
rehabilitation in these patients with prolonged stays in intensive care with 
tracheostomy. 
Source of funding 
Hôpital Forcilles 
Independent 
Supervisory 
Committee 
planned 
None 
Gestionnaire 
Hôpital Forcilles-Fondation Cognacq-Jay 
 
 
 

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Table des matières 
KEY CONTACTS .................................................................................................................. 2 
PROTOCOL VERSION HISTORY ......................................................................................... 3 
SUMMARY OF THE RESEARCH ......................................................................................... 4 
1 
Rationnal ........................................................................................................................ 9 
2 
Hypothèse de recherche ...............................................................................................10 
3 
Objectives .....................................................................................................................10 
3.1 
Main Objective .......................................................................................................10 
3.2 
Secondary objectives .............................................................................................10 
4 
Outcome .......................................................................................................................11 
4.1 
Main outcome .........................................................................................................11 
4.2 
Secondary outcomes ..............................................................................................12 
5 
Patient selection ............................................................................................................13 
5.1 
Inclusion criteria .....................................................................................................13 
5.2 
Non-inclusion criteria ..............................................................................................13 
5.3 
Recruitment procedures .........................................................................................13 
6 
Research design ...........................................................................................................14 
6.1 
Type of study ..........................................................................................................14 
6.2 
Outline of the research ...........................................................................................14 
6.3 
Provisional timetable for the research ....................................................................14 
7 
Description of the usual post-ICU settings management ...............................................15 
7.1 
Medical and nursing procedures .............................................................................15 
7.2 
Weaning from mechanical ventilation .....................................................................15 
7.3 
Early rehabilitation ..................................................................................................16 
7.4 
ICU-acquired muscle weakness assessment .........................................................16 
7.5 
Assessment of swallowing disorders ......................................................................16 
7.6 
Decanulation bronchial fibroscopy ..........................................................................16 
7.7 
Decanulation decision ............................................................................................17 
8 
Assessment procedures added by the research ............................................................19 

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8.1 
Ultrasound measurements .....................................................................................19 
8.2 
Lung ultrasound .....................................................................................................19 
8.3 
Diaphragm ultrasound ............................................................................................19 
9 
Conduct of the study .....................................................................................................20 
9.1 
Pre-inclusion visit ...................................................................................................20 
9.1.1 
Checking inclusion and non-inclusion criteria ..................................................20 
9.1.2 
Patient information and consent ......................................................................20 
9.2 
Inclusion visit ..........................................................................................................21 
9.2.1 
Collection of consent .......................................................................................21 
9.2.2 
Data collection at inclusion ..............................................................................21 
9.3 
End of research visit ................................................................................................22 
9.4 
Bias control ............................................................................................................23 
9.5 
Summary of all visits ..............................................................................................24 
10 
Statistics ....................................................................................................................25 
10.1 
Number of subjects needed ....................................................................................25 
10.2 
General aspects .....................................................................................................25 
10.3 
Main objective ........................................................................................................25 
11 
Expected results in terms of scientific and professional advances .............................26 
12 
Expected benefits and risks for patients .....................................................................26 
12.1 
Minimal risks and constraints added by the research .............................................26 
12.2 
Expected patient benefits .......................................................................................26 
13 
Ethical and regulatory aspects ...................................................................................27 
13.1 
Role of the promoter ...............................................................................................27 
13.2 
Submission to the PPC ..........................................................................................27 
13.3 
Data protection .......................................................................................................27 
13.4 
Insurance ...............................................................................................................28 
13.5 
Substantial amendment to the protocol ..................................................................28 
13.6 
Information note and express consent ....................................................................29 
13.7 
Expected deadline for publication of results in an international journal ...................29 

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13.8 
Data management ..................................................................................................30 
13.9 
Human and financial resources ..............................................................................30 
13.10 
Data properties ...................................................................................................30 
14 
Bibliography ...............................................................................................................31 
15 
Appendices ................................................................................................................34 
15.1 
Appendix 1: CAM-ICU Confusion Assessment Score (26) ......................................35 
15.2 
Appendix 2: MRC Score (28) ..................................................................................36 
15.3 
Appendix 3: Modified Cowling Swallowing Score (18) .............................................37 
15.4 
Appendix 4: Procedure for decanulation bronchial fibroscopy ................................38 
15.5 
Appendix 5: Procedure for lung ultrasound .............................................................39 
15.6 
Appendix 6: Ultrasound Lung Aeration Score (29) ..................................................41 
15.7 
Appendix 7: Lung ultrasound report ........................................................................42 
15.8 
Appendix 8: Diaphragmatic ultrasound ...................................................................43 
15.9 
Appendix 9: Patient information note ......................................................................44 
15.10 
Appendix 10: Information note to the relative ......................................................49 
15.11 
Appendix 11: Patient information note for further research .................................55 
 
 
 
 

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1 Rationnal 
Invasive mechanical ventilation after tracheal intubation is a common ICU procedure to treat 
patients with acute respiratory failure. 
However, even if the acute event is resolved, the length of stay in the ICU may be prolonged 
by the maintenance of prolonged mechanical ventilation. There are many factors that 
contribute to the maintenance of prolonged mechanical ventilation and prevent progress in 
weaning from the ventilator: curarisation, lung infections, pre-existing respiratory disease etc 
(1). 
It has been shown that a delay in weaning is associated with a higher rate of complications in 
the ICU, an increase in the length of stay due to increased neuromyopathy and nutritional 
disorders (undernutrition, swallowing disorders) as well as a decrease in survival in the ICU 
(2)(3). 
In case of prolonged invasive ventilation, after several failed weaning and re-intubation (4), 
these patients are therefore most often tracheotomised by percutaneous or surgical means in 
order to advance in ventilatory weaning. 
The evolution of these tracheostomised patients is long and the difficulties of weaning from 
mechanical ventilation in this population are partly linked to the lack of professional means 
allowing satisfactory rehabilitation before decanulation (5).  
The weaning units, initially created in the United States (6), then in France from the beginning 
of the 2000s, have improved the success rate of weaning in these patients. 
The challenge of tracheal decanulation remains the ultimate goal in these patients. Several 
studies have shown the interest of a multidisciplinary management of these patients: 
physicians, physiotherapists, speech therapists, nurses etc. with their own role in the different 
stages of weaning and decanulation (7)(8)(9)(10). 
The stages of the decanulation process are described in a few studies: switching to 
spontaneous ventilation without occasional mechanical assistance, repeated spontaneous 
ventilation sessions during the day, daytime spontaneous ventilation, daytime and nighttime 
spontaneous ventilation with, in parallel with these progressive sessions, a resumption of 
speech and swallowing (10)(11)(12)(13). 
The factors for successful decanulation are not well known in the literature and the decision to 
decanulate is mainly based on clinical judgement: weaning from mechanical ventilation, normal 
nausea reflex, effective cough, ability to swallow secretions, correct saturation SaO2>90% for 
more than 24 hours (14). 
The failure rate of decanulation is between 2 and 25% (15)(16) with a poor prognosis in case 
of failure (17). 

DESCATRON V3.0 du 14/01/2021 
Thus, the determination of the success factors for decanulation of tracheostomised patients is 
a major challenge to select and optimise the management of these patients. 
 
2 Hypothèse de recherche 
The severity of the resuscitated patient, factors related to invasive ventilation, respiratory and 
extra-respiratory status are independent factors for successful decanulation. 
3 Objectives 
3.1 Main Objective 
The main objective is to determine the factors associated with successful decanulation in 
tracheostomised patients admitted to the Difficult-to-Wean Unit. 
 
3.2 Secondary objectives 
The secondary objectives are to evaluate in tracheostomized patients hospitalized in Difficult-
to-Wean Unit: 
- The prevalence of successful decanulation ; 
- The prevalence of successful weaning from invasive ventilation; 
- Factors associated with successful weaning from invasive ventilation (VI); 
- Demographic characteristics of these patients at admission; 
- The ventilatory characteristics of these patients at admission; 
- Biological characteristics of these patients at admission; 
- The nutritional status of these patients at admission. 
 
 
 

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4 Outcome 
4.1 Main outcome 
Successful decanulation is defined as maintenance of spontaneous ventilation in the absence 
of recanulation, acute use of non-invasive ventilation (NIV) or death within 48 hours. 
Factors potentially associated with successful decanulation will be collected prospectively: 
- Severity factors related to the ICU stay: 
o Total number of oro-tracheal intubations ; 
o Number of days on mechanical ventilation; 
o Curarisation or not with duration 
o Whether or not prone sessions were performed with duration; 
o Whether or not ECMO was used as a back-up; 
o Number of pneumopathies acquired under mechanical ventilation; 
o IGS2 ; 
- Ventilatory factors : 
o Number of failed extubations before tracheostomy in the ICU; 
o Duration of mechanical ventilation before tracheostomy in the ICU (days); 
o Type of tracheostomy used: percutaneous or surgical; 
o Time to first attempt at Difficult-to-Wean Unit de-ventilation (days); 
o Time to 24-hour at Difficult-to-Wean Unit de-ventilation (days); 
o Time from 24-hour deventilation to successful DIFFICULT-TO-WEAN UNIT 
decanulation (days); 
o Number of ventilator-associated lung diseases (VAPs) in at Difficult-to-Wean Unit; 
- Respiratory factors:  
o Ultrasound lung ventilation score on admission to at Difficult-to-Wean Unit; 
o Diaphragmatic dysfunction on admission to at Difficult-to-Wean Unit; 
o Bronchial fibroscopy abnormalities prior to decanulation;  
- Extra-respiratory factors: 
o Confusional state on admission to at Difficult-to-Wean Unit (CAM-ICU, Appendix 1); 
o Existing swallowing disorders (assessed after 6 hours of ventilation) by the modified 
Cowling swallowing score (18); 
o Oral status on admission to at Difficult-to-Wean Unit (normal, moderately impaired, 
dilapidated, no teeth); 
o ICU-Acquired muscle weakness (MRC score) on admission to at Difficult-to-Wean Unit; 

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4.2 Secondary outcomes 
- Proportion of successful decanulation among all included patients (prevalence of successful 
decanulation) ; 
- Proportion of successful weaning from IV among all included patients (prevalence of 
successful weaning from IV). Successful weaning from invasive ventilation is defined as the 
absence of invasive ventilation >48h ; 
- The same factors potentially associated with successful weaning from IV will be collected as 
described in section 4.1.  
- Collection of biological parameters within the first 48 hours of admission to Difficult-to-Wean 
Unit: haemoglobin, leukocytes, lymphocytes, neutrophils, troponin, renal function (urea, 
creatinine, GFR), metabolic function (calcium, magnesium, phosphate, TSH, cortisol at 8 
hours, 25(OH)D) and inflammatory function (albumin, CRP); 
- Ventilatory parameters on admission to Difficult-to-Wean Unit: ventilatory mode (VAC, VSAI), 
ventilatory settings (FiO2, PEP, AI, FR, Vt); 
- Demographic characteristics of these patients during Difficult-to-Wean Unit hospitalisation: 
mortality, length of hospitalisation, duration of invasive ventilation. 
- Nutritional assessment by evaluation of grip strength by Handgrip at admission and discharge 
from the Difficult-to-Wean Unit, by evaluation of the stage of sacral eschar at admission to the 
DIFFICULT-TO-WEAN UNIT, by measurement of resting energy expenditure by calorimetry at 
admission to the DIFFICULT-TO-WEAN UNIT and by measurement of lean mass, fat mass 
and dilution by impedancemetry at admission to the Difficult-to-Wean Unit. 
 
 
 

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5 Patient selection 
5.1 Inclusion criteria 
- Admission to DIFFICULT-TO-WEAN UNIT at Forcilles Hospital; 
- Presence of a tracheotomy on admission to Difficult-to-Wean Unit; 
- Presence of invasive ventilation on admission to Difficult-to-Wean Unit with a predicted 
duration of > 48 hours; 
- Patient aged at least 18 years at the time of inclusion; 
- Affiliation to or beneficiary of a social security scheme; 
- Oral, free, informed and express consent of the patient or a relative. 
 
5.2 Non-inclusion criteria 
- Known pregnancy ; 
- Person subject to a legal protection measure; 
- Person under guardianship or curatorship; 
- Refusal of access to data by the patient or the designated trusted person. 
 
5.3 Recruitment procedures 
Patients will be recruited prospectively and consecutively from the Difficult-to-wean Unit 
(=Post-ICU settings) of the Forcilles Hospital following an ICU stay. One of the investigating 
physicians will identify the patient upon confirmation of transfer from an ICU to the Difficult-to-
Wean Unit. 
 
 

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6 Research design 
6.1 Type of study 
This is a prospective, monocentric, interventional cohort study with minimal risk and constraints 
falling under 2° of article L.1121-1 of the Public Health Code (Category 2, Jardé law). 
 
6.2 Outline of the research 
 
 
 
6.3 Provisional timetable for the research 
The duration of recruitment will be 24 months with a follow-up of patients for 1 month, i.e. a 
total duration of the study estimated at 25 months. 
- PPC submission: November 2020; 
- Start of inclusion: January 2021; 
- Duration of the inclusion period: 2 years; 
- Duration of participation of each patient: 1 month (average length of stay in DIFFICULT-TO-
WEAN UNIT); 
- End of inclusions: January 2023; 
- Total duration of the research: 2 years and 1 month; 
- Communication in congresses: National and international congresses in intensive care and 
anesthesiology;  
- Publication: July 2023 

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7 Description of the usual post-ICU settings management 
There will be no change to the usual management of Difficult-to-Wean Unit inpatients under 
this protocol. 
7.1 Medical and nursing procedures 
Medical procedures for diagnostic or therapeutic purposes and nursing care will be carried out 
in the usual way, respecting hygiene measures. These procedures consist of all the treatments 
and care usually provided to a patient hospitalised in a Difficult-to-Wean Unit, mainly 
- Treatment of respiratory failure; 
- Treatment of co-morbidities; 
- Measures to prevent and treat complications related to inpatient care. 
Similarly, in order to be able to evaluate and adapt the management of the patient in the 
Difficult-to-Wean Unit as best as possible, an entry biological assessment is carried out within 
48 hours of admission. The biological assessment includes the following elements: 
haemoglobin, leucocytes, lymphocytes, neutrophils, troponin, renal function (urea, creatinine, 
GFR), metabolic function (calcium, magnesium, phosphate, TSH, cortisol at 8 hours, 25(OH)D) 
and inflammatory function (albumin, CRP) 
Morphological characteristics (height, weight) are measured in the usual way on admission of 
the patient in order to adapt the nutritional management. 
 
7.2 Weaning from mechanical ventilation 
Patients admitted to Difficult-to-Wean Unit will be tracheostomised and invasively ventilated in 
a difficult or prolonged weaning situation (4). 
Causes of weaning failure or decanulation (cardiac, respiratory, neurological, muscular, etc.) 
will be treated according to good practice guidelines. 
 
 

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7.3 Early rehabilitation 
Patients admitted to the DIFFICULT-TO-WEAN UNIT receive early rehabilitation as part of the 
prevention and treatment of complications related to ICU hospitalisation. 
Rehabilitation will be carried out in the usual way by the teams of physiotherapists, speech 
therapists, nurses and care assistants (according to their respective skills). The rehabilitation 
intervention is prescribed by the doctor. In the absence of a specific indication from the doctor, 
the physiotherapist or speech therapist chooses the type of rehabilitation act according to the 
patient's condition. 
The frequency of rehabilitation will depend on the doctor's prescription if it specifies it, on the 
habits and resources of the department and on the patient's condition. 
 
7.4 ICU-acquired muscle weakness assessment 
ICUAW is assessed using the MRC score, performed by the ward physiotherapists on 
admission of the patient. The MRC score is widely used in resuscitation patients to detect 
acquired muscle weakness (19)(20). The score assesses 3 muscle groups for each of the 
upper and lower limbs. Each muscle group will be scored between 0 and 5 according to the 
voluntary strength developed. An overall score out of 60 is calculated (Appendix 2). 
 
7.5 Assessment of swallowing disorders 
As part of the patient's speech and language therapy, an assessment of swallowing disorders 
is carried out by a member of the speech and language therapy team when the patient tolerates 
several hours of deventilation per day.  
For this purpose, we will use the modified Cowling swallowing score which consists of 4 points 
(Appendix 3): no disorder, abnormality to solids, abnormality to liquids, abnormality to liquids 
and solids. 
The assessment is based on the detection of liquid, solid or liquid and solid false routes by 
ingestion techniques of coloured or uncoloured liquids/foods with the search for these potential 
false routes in the airways via tracheal aspirations through tracheostomy. 
 
7.6 Decanulation bronchial fibroscopy 
As part of the patient's laryngeal and pulmonary assessment prior to tracheostomy 
decanulation, a bronchial fibroscopy will be performed as a matter of routine by the 
department's physicians. 

DESCATRON V3.0 du 14/01/2021 
The objectives of this fibroscopy are described in Appendix 4. The objectives are the evaluation 
of the ENT sphere with the search for oedema of the hypopharynx, the arytenoids, the 
evaluation of the mobility of the vocal cords and the evaluation of the sensitivity of the 
hypopharynx. The assessment is followed by an evaluation of the trachea, including the 
positioning of the tracheostomy cannula, the existence of tracheal ring fractures, the search 
for granuloma, tracheomalacia and bronchomalacia. 
 
7.7 Decanulation decision 
The decision to decanulate follows a progressive de-ventilation and assessment protocol 
based on respiratory and extra-respiratory criteria: 
 
Respiratory criteria : 
- Patient under mechanical ventilation 24 hours a day: the tracheostomy cannula is a non-
windowed or a windowed cannula with a low pressure cuff of the Silhey® LPC, Bivona® Mid-
Range Air Cuf or Portex® Blue-Line Ultra type; allowing to limit the risks of tracheal lesions 
due to the cuff; 
 
- Patient under mechanical ventilation <18h/24h or dislocated > 6h/24h (with the cuff of the 
tracheostomy cannula deflated): the cannula is changed for a non fenestrated high pressure 
cuffed cannula such as Bivona® TTS. This type of cannula is with a plated silicone cuff and is 
very well tolerated and facilitates speech therapy exercises. The size of the tracheostomy 
cannula is sometimes reduced to facilitate the exercises but this is not consensual and is more 
a matter of practice specific to each department. 
 
- Patient discharged during the day: generally 8am-6pm, then progressive lengthening of the 
time before nocturnal reventilation (plateau at 8pm-10pm-00am). 
 
- Patients discharged during the day and early evening: this discharging is continued 
throughout the night. Complete 24-hour de-ventilation is recorded when the patient is de-
ventilated for 48 hours without the need for re-ventilation. 
 
- Patient is deventilated 24 hours a day: the next step consists of placing a plug over the 
tracheostomy orifice. Thus, the patient's "classical" respiratory tract is used and the patient is 
in a respiratory situation equivalent to a patient without a tracheostomy tube. 
 
Extra-respiratory criteria: 

DESCATRON V3.0 du 14/01/2021 
After 48 hours with the cannula plugged, in the absence of a respiratory event, the patient is 
considered decanulable. Various assessments are carried out to ensure that there are no 
potentially negative predictive factors: 
- Speech therapy: pharyngolaryngeal oedema is assessed by phonation exercises. These 
exercises can also be used to assess vocal cord and/or glossal damage. Swallowing of liquids 
and solids is tested. 
- Physiotherapy: neuromuscular and diaphragmatic function (MRC score, ultrasound) are 
assessed. 
 
Decanulation is possible when the patient does not have a major swallowing disorder, 
pharyngo-laryngeal oedema or laryngeal sensitivity disorder with risk of passive false routes 
(salivary or food) and when muscle recovery, absence or recovery of diaphragmatic 
dysfunction and trunk tone are satisfactory. 
 
These extra-respiratory parameters are intimately linked to respiratory progress. Indeed, 
without satisfactory neuromuscular recovery, without orthophonic reinforcement of swallowing, 
the patient will not be able to progress on the ventilatory level. 
 
Once all the parameters are satisfactory and a decanulation fibroscopy does not reveal any 
anomaly contraindicating decanulation, the tracheostomy cannula is removed.  To do this, the 
cannula is simply removed and an occlusive dressing is placed over the tracheal orifice. This 
usually closes within 3 to 5 days. 
 
 

DESCATRON V3.0 du 14/01/2021 
8 Assessment procedures added by the research 
The collection of data and the examinations necessary for the evaluation criteria will be carried 
out by one of the investigators not involved in the management of the patient. 
 
8.1 Ultrasound measurements 
The ultrasound measurements will be performed by one of the physiotherapists or investigating 
physicians. The physiotherapist is entitled to perform ultrasound subject to training (21). 
All the physiotherapists investigators have been trained according to the teaching 
recommendations for lung ultrasound (22) and are already involved in other research projects 
using lung and diaphragm ultrasound (https://clinicaltrials.gov/ct2/show/NCT02474797 and 
https://clinicaltrials.gov/ct2/show/NCT02881814). 
When a physiotherapist performs an ultrasound scan, a referring resuscitation physician will 
be present to control the execution of the examination and to ensure that the recommendations 
of practice are respected. He will also ensure that the patient's management is not modified 
during the examination. The referring resuscitators are resuscitators trained in ultrasound 
(either through a diploma, qualifying training or acquired during their clinical experience) and 
named below Dr Gérald CHOUKROUN, Dr Pascal MEYER and Dr Jean-Baptiste PERETOUT. 
 
8.2 Lung ultrasound 
Lung ultrasound will be performed as described in Appendix 5. It is used to assess the state 
of lung ventilation (Appendix 5). A score from 0 to 3 (normal ventilation to complete loss of 
ventilation, respectively) is applied to each thoracic region. An overall lung aeration score out 
of 36 is calculated (Appendix 6). An ultrasound report is written (Appendix 7). 
 
8.3 Diaphragm ultrasound 
Ultrasound of the diaphragm will assess the excursion (mobility) and thickening of the 
diaphragm on the right and left. The procedure is described in Appendix 8. Each measurement 
will be repeated 3 times, the best one will be retained. 
 

DESCATRON V3.0 du 14/01/2021 
9 Conduct of the study 
9.1 Pre-inclusion visit 
9.1.1 Checking inclusion and non-inclusion criteria 
When a patient is admitted to the Difficult-to-Wean Unit, one of the investigators checks the 
presence of inclusion criteria and the absence of non-inclusion criteria in the hospital admission 
report (HIR), during the admission visit and in the patient's computerised record. 
 
9.1.2 Patient information and consent 
When all the criteria allow the inclusion of the patient, the investigating physician informs the 
patient of the purpose of the study during a room visit. He provides the patient with all the 
information described in the information note (Appendix 9). 
The state of consciousness of certain patients (under temporary sedation) when they are 
admitted to the Difficult-to-Wean Unit will not allow them to receive information related to the 
research and the collection of consent, and the information will be given to the person close to 
them who has been declared a trusted person (Appendix 10). As soon as the patient is awake, 
he or she will be informed of the research and asked for express oral consent to continue the 
research (Appendix 11). Decanulation only takes place when the patient is awake and 
compatible with good swallowing and satisfactory neuromuscular function. 
In the event of a new ban on visits to hospital departments due to the health crisis, information 
and oral consent from the trusted support person will be given by telephone or 
videoconference. 
 
 

DESCATRON V3.0 du 14/01/2021 
9.2 Inclusion visit 
All the data collected will be entered in the CRF.. 
 
9.2.1 Collection of consent 
After sufficient time for reflection, the patient's or the patient's relative's express oral consent 
should be obtained. The date on which the patient or the patient's relative agreed to participate 
in the research is recorded in the computerised medical record, as is the date of withdrawal of 
participation, if any. 
In the event that a patient's relative has given oral express consent, the patient will be informed 
of this research as soon as possible and asked for oral express consent for the possible 
continuation of the research (Appendix 11). 
 
9.2.2 Data collection at inclusion 
At the inclusion visit, the following data will be collected from the patient's computerised 
medical record, or directly from the patient or relative if data is missing: 
- Age, sex (male/female), weight, height, body mass index (BMI); 
- Medical history: chronic heart disease (hypertension, coronary artery disease, dyslipidaemia, 
rhythm disorder), diabetes, chronic respiratory disease (Chronic Obstructive Pulmonary 
Disease (COPD), Sleep Apnoea Hypopnoea Syndrome (SAHOS), neurological disease, 
cancer, chronic renal failure, smoking (active, weaned, no), chronic alcoholism (yes, no); 
- Data related to the initial ICU stay: 
o Type of intensive care unit (medical, surgical, polyvalent) and type of institution 
(public, private non-profit, private); 
o Reason for admission to intensive care: acute respiratory failure (ARF), ARF on 
chronic respiratory failure (CRF), cardiogenic shock, septic shock, haemorrhagic shock, 
polytrauma, post-operative, cardiorespiratory arrest (CRA), stroke, burns, pancreatitis, coma; 
o IGS2 score on initial admission to the ICU. 
- Number of failed extubations; 
- Total duration of oro-tracheal intubation before tracheostomy (days); 
- Number of VAPs (days); 
- Performance of prone sessions (yes/no); 
- If applicable, total duration of prone position (days); 
- Use of ECMO support (veno-venous/arteriovenous/no); 
- Tracheostomy performed (percutaneous/surgical/not); 
- Resuscitation neuromyopathy (yes/no); 

DESCATRON V3.0 du 14/01/2021 
- Presence of BMR/BHR (yes/no); 
- Limitation and discontinuation of active therapies (LATA) in the ICU (yes/no); 
- Length of stay in intensive care (days); 
- Type of tracheostomy cannula: uncuffed fenestrated, cuffed fenestrated, uncuffed non 
fenestrated, cuffed non fenestrated; 
- Cannula model (Shiley/Bivona/Trachoe/Other); 
- Presence of mechanical ventilation (yes/no) and parameters: 
o Mode: Controlled/PS/Other 
o PS, PEEP, Vt, HR 
o FiO2 (%) 
- Biological check-up on admission within 48 hours of admission to DIFFICULT-TO-WEAN 
UNIT: haemoglobin, leucocytes, lymphocytes, neutrophils, troponin, renal function (urea, 
creatinine, GFR), metabolic function (calcium, magnesium, phosphate, TSH, cortisol at 8 
hours, 25(OH)D) and inflammatory function (albumin, CRP); 
- MRC score; 
- Pulmonary ultrasound ; 
- Diaphragmatic ultrasound; 
- Confusional state by CAM-ICU (yes/no) (Appendix) ; 
- Oral status (normal/moderate impairment/decay/no teeth); 
- Vocal status (normal/minimal alteration/severe alteration/absence); 
- Swallowing disorders by modified Cowling score (liquids/solids/both/not); 
- Presence of undernutrition (severe/moderate/minimal/no); 
- Presence of a nasogastric tube (yes/no); 
- Presence of a percutaneous gastrostomy (yes/no); 
- Oral feeding resumed (yes/no). 
 
For data collection regarding the ICU hospitalisation prior to DIFFICULT-TO-WEAN UNIT 
hospitalisation, this will be done on the basis of hospitalisation reports and, if necessary, by 
requesting additional information through telephone calls to the ICU services or the attending 
physician. 
 
9.3 End of research visit 
The end-of-research visit will be carried out when the patient is discharged from the 
DIFFICULT-TO-WEAN UNIT. The necessary additional information will be collected from the 
patient's computerised medical record. 
The variables collected are : 

DESCATRON V3.0 du 14/01/2021 
- Time to spontaneous ventilation (days) ; 
- Time to 1st attempt at de-ventilation (days); 
- Time to 24-hour de-ventilation (days); 
- Time between 24-hour deventilation and successful final decanulation (days); 
- Number of decanulations performed; 
- Performance of a decanulation bronchial fibroscopy (yes/no) with abnormalities observed: 
o pharyngeal oedema ; 
o unilateral vocal cord paralysis; 
o Bilateral vocal cord paralysis; 
o unilateral arytenoid palsy 
o bilateral arytenoid palsy; 
o Tracheal ring fracture; 
o No abnormality observed. 
- Number of VAPs in DIFFICULT-TO-WEAN UNIT ; 
- Total duration of antibiotic therapy (days) ; 
- MRC score; 
- Presence of undernutrition (severe/moderate/minimal/no); 
- Presence of a nasogastric tube (yes/no); 
- Presence of a percutaneous gastrostomy (yes/no); 
- Oral feeding resumed (yes/no); 
- Mode of discharge (return to intensive care, return home, death). 
 
9.4 Bias control 
In order to limit a possible measurement bias, the MRC score, the ultrasound measurements 
and the fibroscopic evaluation will be performed by one of the investigating physicians or 
physiotherapists, according to their respective competences, who are not part of the patient's 
care team. 
 
 
 

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9.5 Summary of all visits 
Données/actes 
Pré-
inclusion 
Inclusion 
Fin de recherche 
Recueil dans le CRH en réanimation, le DMI ou auprès du patient/proche 
Information du patient ou du 
proche 
X 
 
 
Consentement du patient ou du 
proche 
 
X 
 
Données 
anthropométriques 
(âge, poids, taille, sexe, IMC) 
 
X 
 
Antécédents médicaux 
 
X 
 
Données liées au séjour initial en 
réanimation 
 
X 
 
Données liées à la ventilation : 
trachéotomie, VM (modes et 
paramètres) 
 
X 
 
Etapes 
sevrage 
ventilatoire 
(temps 
avant 
déventilation 
journée, 
temps 
avant 
déventilation complète) 
 
 
X 
Durée de séjour en SRPR 
 
 
X 
Modalités de sortie du SRPR 
 
 
X 
Mesures cliniques, physiologiques et biologiques 
Bilan biologique (urée, créatinine, 
DFG, troponine, Hb, leucocytes, 
PNN, 
lymphocytes, 
calcium, 
magnesium, phosphates 
 
X 
 
Albumine, pré-albumine, CRP, 
25(OH)D, TSH, cortisol à 8h 
 
X 
 
Scores fonctionnels 
MRC 
 
X 
X 
Hand-grip 
 
x 
X 
Calorimétrie 
 
X 
 
Impédancemétrie :masse 
maigre, masse grasse, dilution 
 
X 
 
Echographie 
 
 
Diaphragme 
 
X 
X 
Pulmonaire 
 
X 
X 
Nutrition 
Alimentation PO, entérale par 
GEP ou SNG 
 
X 
X 
Orthophonie 
Troubles déglutition, état bucco 
dentaire, voix, état confusionnel 
 
X 
 
 
 
 
 

DESCATRON V3.0 du 14/01/2021 
10 Statistics 
10.1 Number of subjects needed 
The calculation of the number of subjects required is based on the number of explanatory 
variables to be included in the multiple logistic regression model to determine the factors 
associated with successful decanulation. The "1 variable per 10 events" rule is applied. (23)  
We anticipate 6 variables to be included in the final multivariate predictive model, after 
selection of variables in univariate analysis, based on an estimated 60% success of 
decanulation (retrospective estimate on data available in the department), i.e. a necessary 
number of subjects of 100 patients. 
 
10.2 General aspects 
Descriptive statistics will be based on the use of means (± standard deviation) or medians 
(interquartile range) depending on the distribution of quantitative variables. Qualitative 
variables will be described in terms of numbers and percentages. 
Univariate analyses will use the usual statistical tests after checking the distribution of the 
variables (Chi2 or Fisher's test; t-test, ANOVA or their non-parametric equivalents, Wilcoxon 
and Kruskal-Wallis tests). The Shapiro-Wilk test will be used to check whether the distribution 
of the data follows a normal distribution. 
The multivariate analyses will be carried out by linear or multiple logistic regression models, 
depending on the type of variables. 
The tests will be carried out with a significance level of 5%. The calculations will be made using 
R software (version 3.6.1, www.R-project.org) and Stata 15.0. 
 
10.3 Main objective 
Patients will be classified into 2 groups: success or failure of decanulation. The variables 
collected will be compared between the 2 groups by the appropriate tests according to the type 
of variables (quantitative or qualitative) and their distribution. The results of these comparisons 
will be used to select the variables showing a difference between the 2 groups (p < 0.20) for 
inclusion in the multivariate logistic regression. (24)(25) 
The previously selected ultrasound variables will be included in the model predicting the 
success of decanulation. Multiple logistic regression with variable selection using the Akaike 
information criterion (AIC) method will be used. The presence of multicollinearity between 
variables will also be investigated and the variable eliminated if necessary. 

DESCATRON V3.0 du 14/01/2021 
 
11 Expected results in terms of scientific and professional 
advances 
This study will determine the factors contributing to the success of decanulation in patients 
admitted to DIFFICULT-TO-WEAN UNIT after a prolonged ICU stay. The evaluation of these 
success factors will provide data that is still lacking due to the lack of literature in specialised 
post-resuscitation ventilatory weaning facilities. 
This information may be useful in the post-resuscitation follow-up and in the prioritisation or 
not of early rehabilitation in these patients. 
 
12 Expected benefits and risks for patients 
12.1 Minimal risks and constraints added by the research 
The risks and constraints for the patient will be minimal.   
They are mainly related to the extra time the patient will spend on the initial assessment by the 
physiotherapy team with the ultrasound. Ultrasound is a non-invasive, non-irradiating and 
totally painless tool. 
The other procedures are an integral part of the conventional management of tracheostomised 
patients in DIFFICULT-TO-WEAN UNIT. 
 
12.2 Expected patient benefits 
This study will improve our knowledge of the factors involved in the success of ventilatory 
weaning in tracheostomised patients. 
This will provide information on the elements involved in the success of decanulation in this 
patient population in order to best adapt the management in early rehabilitation and 
potentially adapt the therapeutic conduct. 
The data collected will also provide information on the clinical and biological profile of 
patients admitted to DIFFICULT-TO-WEAN UNIT. 
 

DESCATRON V3.0 du 14/01/2021 
13 Ethical and regulatory aspects 
The Forcilles-Fondation Cognacq-Jay hospital promoter and the person(s) directing and 
supervising the research undertake to ensure that this research is carried out in accordance 
with law n°2004-806 of 9 August 2004 relating to public health policy and the regulatory 
provisions in force (articles L.1121-1, L.1121-2 and L.1121-3 of the Public Health Code. The 
data recorded during this research will be subject to computerised processing in compliance 
with law n°78-17 of 6 January 1978 relating to information technology, files and freedoms, 
amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 1° August 2018) and 
order n° 2018-1125 of 12 December 2018. 
The research will be conducted in accordance with this protocol. 
 
13.1 Role of the promoter 
The research commission of the Forcilles-Fondation Cognacq-Jay hospital, promoter of this 
research, submits the file to the opinion of the relevant Comité de Protection des Personnes 
(CPP) (CPP Ouest III) whose opinion will be notified in the information note intended for the 
persons concerned. 
The natural or legal person who initiates the research, manages it and ensures that it is 
financed is called the sponsor. 
 
13.2 Submission to the PPC 
This research will be submitted to a Committee for the Protection of Individuals, which will be 
drawn by lot within the framework of the "Jardé law" (article L.1121-4 of the Public Health 
Code, decree no. 2016-1537 of 16 November 2016, which came into force on 18 November 
2016). 
The opinion of the above-mentioned committee is notified in the information note intended for 
the persons concerned. A copy of this opinion and a summary of the research will be sent to 
the ANSM. 
 
13.3 Data protection 
This research is subject to law n°78-17 of 6 January 1978 relating to information technology, 
files and freedoms as amended by law n° 2018-493 of 20 June 2018 (decree n° 2018-687 of 
1 August 2018). Information on the rights of persons participating in this research (right of 
access and rectification, right to object to the transmission of data covered by professional 

DESCATRON V3.0 du 14/01/2021 
secrecy likely to be used in the context of this research) is included in the information note 
intended for the patient. 
A reference methodology specific to the processing of personal data carried out in the context 
of biomedical research defined by Law 2004-806 of 9 August 2004 as falling within the scope 
of Articles L.1121-1 et seq. of the Public Health Code was updated by the CNIL in May 2018 
(Deliberation No. 2018-153 of 3 May 2018) following the publication of European Regulation 
No. 2016/679 (General Data Protection Regulation). This methodology allows a simplified 
declaration procedure when the nature of the data collected in the research is compatible with 
the list provided by the CNIL in its reference document. This study is part of the MR001 
reference methodology to which the Forcilles-Fondation Cognacq-Jay hospital has committed 
to comply. 
 
13.4 Insurance 
The Sponsor takes out insurance covering its own civil liability and that of any person involved 
in the performance of the research for the entire duration of the research, regardless of the 
nature of the links between the participants and the Sponsor (Article L.1121-10 of the Public 
Health Code). The sponsor is also responsible for the compensation of the harmful 
consequences of the research for the person who undergoes it and for that of his or her 
dependents, unless it can be proved that the damage is not attributable to its fault or to that of 
any other party involved, without the possibility of invoking the act of a third party or the 
voluntary withdrawal of the person who initially agreed to undergo the research. Where the 
sponsor is not liable, the victims may be compensated under the conditions set out in Article 
L.1142-3. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability as well as that of any intervening party with the company 
SHAM for the entire duration of the research, in accordance with article L.1121-10 of the Public 
Health Code. 
 
13.5 Substantial amendment to the protocol 
The investigator or coordinator informs the research commission of the Forcilles-Fondation 
Cogacq-Jay hospital of any proposed modification of the protocol. Any substantial modification 
will be submitted by the sponsor of this research to the CPP for its opinion. 
 
 
 

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13.6 Information note and express consent 
In accordance with Article L.1122-1 of the Public Health Code, the information provided to the 
persons who are to be involved in the research is the subject of a written document submitted 
in advance to the personal protection committee. The ethical opinion of the CPP Ouest III has 
been requested. 
The investigator at the centre offers the patient, or a relative if the patient is incapacitated, to 
participate in the study. The investigator informs the patient orally of the terms of the study and 
gives him/her the information note. If the patient gives free, informed and express oral consent 
to participate in the protocol, the information given orally and in writing, as well as the collection 
of oral consent, will be recorded in the patient's medical record. 
In the event that a relative of the patient has given consent, as soon as possible, the patient 
will be informed of the research and asked for oral consent for the possible continuation of the 
research. 
Patients are free to participate or withdraw from the study at any time in accordance with Article 
21 of the GDPR. Data collected until the patient withdraws consent will be used unless the 
patient expressly requests otherwise. The withdrawal of consent by the patient and the 
agreement to use or not the data previously collected will be traced in the patient's medical 
file. 
When the research is completed, the person who is to be the subject of the research may be 
informed of the overall results of the research in a manner to be specified in the information 
document. 
 
13.7 Expected deadline for publication of results in an international 
journal 
The deadline for the publication of the results is 30 months. 
 
 
 

DESCATRON V3.0 du 14/01/2021 
13.8 Data management 
For each subject, an identification code (corresponding to the centre number-inclusion 
number-Initial Surname-Initial First Name) will be assigned. The data collected will be 
confidential and coded (only the identification code will appear). The concordance table linking 
the assigned identification code and the participant's name will be kept by the principal 
investigator in a file with computer restricted access rights. The data will be entered into a 
password protected Excel® file held by the principal investigator. Data processing and 
statistical analysis will be carried out at the Forcilles-Fondation Cognacq-Jay hospital. 
The promoter is the owner of the data and no use or transmission to a third party can be made 
without his prior agreement. 
The specific documents of a type 2 interventional research ("Loi Jardé", decree n° 2016-1537 
of 16 November 2016, which came into force on 18 November 2016) with minimal risks and 
constraints will be archived by all parties for a period of 15 years after the end of the research. 
This indexed archive includes : 
- 
successive versions of the protocol (identified by version number and date); 
- 
correspondence ; 
- 
the inclusion list or register ; 
- 
the data collection document ; 
- 
research-specific annexes ; 
- 
the final report of the research. 
The database used for the statistical analysis must also be archived by the person responsible 
for the analysis (paper or computer). 
 
13.9 Human and financial resources 
The Forcilles-Fondation Cognacq-Jay hospital is equipped with human, material and technical 
resources to carry out this research project. 
 
13.10 Data properties 
The Forcilles-Fondation Cognacq-Jay Hospital is the owner of the data and no use or 
transmission to a third party may be made without its prior agreement. 
 
 

DESCATRON V3.0 du 14/01/2021 
14 Bibliography 
 
1.  
Shin H-J, Chang J-S, Ahn S, Kim T-O, Park C-K, Lim J-H, et al. Clinical factors 
associated with weaning failure in patients requiring prolonged mechanical ventilation. J 
Thorac Dis. janv 2017;9(1):143‑50.  
2.  
Epstein SK, Ciubotaru RL. Independent effects of etiology of failure and time to 
reintubation on outcome for patients failing extubation. Am J Respir Crit Care Med. août 
1998;158(2):489‑93.  
3.  
Thille AW, Richard J-CM, Brochard L. The decision to extubate in the intensive care 
unit. Am J Respir Crit Care Med. 15 juin 2013;187(12):1294‑302.  
4.  
Boles J-M, Bion J, Connors A, Herridge M, Marsh B, Melot C, et al. Weaning from 
mechanical ventilation. Eur Respir J. mai 2007;29(5):1033‑56.  
5.  
Boynton JH, Hawkins K, Eastridge BJ, O’Keefe GE. Tracheostomy timing and the 
duration of weaning in patients with acute respiratory failure. Crit Care Lond Engl. août 
2004;8(4):R261-267.  
6.  
Scheinhorn DJ, Chao DC, Stearn-Hassenpflug M, Wallace WA. Outcomes in post-ICU 
mechanical 
ventilation: 
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protocol. 
Chest. 
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2001;119(1):236‑42.  
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Welton C, Morrison M, Catalig M, Chris J, Pataki J. Can an interprofessional 
tracheostomy team improve weaning to decannulation times? A quality improvement 
evaluation. Can J Respir Ther CJRT Rev Can Ther Respir RCTR. 2016;52(1):7‑11.  
8.  
Thomas S, Sauter W, Starrost U, Pohl M, Mehrholz J. Time to decannulation and 
associated risk factors in the postacute rehabilitation of critically ill patients with intensive care 
unit-acquired weakness: a cohort study. Eur J Phys Rehabil Med. août 2017;53(4):501‑7.  
9.  
Gundogdu I, Ozturk EA, Umay E, Karaahmet OZ, Unlu E, Cakci A. Implementation of 
a respiratory rehabilitation protocol: weaning from the ventilator and tracheostomy in difficult-
to-wean patients with spinal cord injury. Disabil Rehabil. 2017;39(12):1162‑70.  
10.  
Mah JW, Staff II, Fisher SR, Butler KL. Improving Decannulation and Swallowing 
Function: A Comprehensive, Multidisciplinary Approach to Post-Tracheostomy Care. Respir 
Care. févr 2017;62(2):137‑43.  
11.  
Everitt E. Managing the weaning of a temporary tracheostomy. Nurs Times. 18 mai 
2016;112(20):17‑9.  
12.  
Pandian V, Miller CR, Schiavi AJ, Yarmus L, Contractor A, Haut ER, et al. Utilization of 
a standardized tracheostomy capping and decannulation protocol to improve patient safety. 
The Laryngoscope. août 2014;124(8):1794‑800.  

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13.  
Zanata I de L, Santos RS, Hirata GC. Tracheal decannulation protocol in patients 
affected by traumatic brain injury. Int Arch Otorhinolaryngol. avr 2014;18(2):108‑14.  
14.  
Choate K, Barbetti J, Currey J. Tracheostomy decannulation failure rate following 
critical illness: a prospective descriptive study. Aust Crit Care Off J Confed Aust Crit Care 
Nurses. févr 2009;22(1):8‑15.  
15.  
O’Connor HH, White AC. Tracheostomy decannulation. Respir Care. août 
2010;55(8):1076‑81.  
16.  
Bach JR, Saporito LR. Indications and criteria for decannulation and transition from 
invasive to noninvasive long-term ventilatory support. Respir Care. mai 1994;39(5):515‑28; 
discussion 529-531.  
17.  
Singh RK, Saran S, Baronia AK. The practice of tracheostomy decannulation-a 
systematic review. J Intensive Care. 2017;5:38.  
18.  
Cowling, Hale, Grundy. Management of malignant oesophageal obstruction withself-
expanding metallic stents. Br J Surg. févr 1998;85(2):264‑6.  
19.  
Kress JP, Hall JB. ICU-Acquired Weakness and Recovery from Critical Illness. N Engl 
J Med. 24 avr 2014;370(17):1626‑35.  
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De Jonghe B. Paresis Acquired in the Intensive Care UnitA Prospective Multicenter 
Study. JAMA. 11 déc 2002;288(22):2859.  
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CNOMK. AVIS DU CONSEIL NATIONAL DE L’ORDRE DU 27 MARS 2015 MODIFIE 
LE 24 SEPTEMBRE 2015 ET RELATIF A L’ECHOGRAPHIE. 2015.  
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Royal College of Radiologists (Great Britain). Ultrasound training recommendations for 
medical and surgical specialties. London: The Royal College of Radiologists; 2005.  
23.  
van Smeden M, de Groot JAH, Moons KGM, Collins GS, Altman DG, Eijkemans MJC, 
et al. No rationale for 1 variable per 10 events criterion for binary logistic regression analysis. 
BMC Med Res Methodol. 24 2016;16(1):163.  
24.  
Fardet L, Galicier L, Lambotte O, Marzac C, Aumont C, Chahwan D, et al. Development 
and validation of the HScore, a score for the diagnosis of reactive hemophagocytic syndrome. 
Arthritis Rheumatol Hoboken NJ. sept 2014;66(9):2613‑20.  
25.  
Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease 
classification system. Crit Care Med. oct 1985;13(10):818‑29.  
26.  
Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, et al. Delirium in 
Mechanically Ventilated Patients: Validity and Reliability of the Confusion Assessment Method 
for the Intensive Care Unit (CAM-ICU). JAMA. 5 déc 2001;286(21):2703.  
27.  
Knyrim K, Wagner H-J, Bethge N, Keymling M, Vakil N. A Controlled Trial of an 
Expansile Metal Stent for Palliation of Esophageal Obstruction Due to Inoperable Cancer. N 
Engl J Med. 28 oct 1993;329(18):1302‑7.  

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28.  
Kleyweg RP, Van Der Meché FGA, Schmitz PIM. Interobserver agreement in the 
assessment of muscle strength and functional abilities in Guillain-Barré syndrome: Muscle 
Strength Assessment in GBS. Muscle Nerve. nov 1991;14(11):1103‑9.  
29.  
Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby J-J. Bedside Ultrasound 
Assessment of Positive End-Expiratory Pressure–induced Lung Recruitment. Am J Respir Crit 
Care Med. févr 2011;183(3):341‑7.  
30.  
Soummer A, Perbet S, Brisson H, Arbelot C, Constantin J-M, Lu Q, et al. Ultrasound 
assessment of lung aeration loss during a successful weaning trial predicts postextubation 
distress*: Crit Care Med. juill 2012;40(7):2064‑72.  
 
 

DESCATRON V3.0 du 14/01/2021 
15 Appendices 
 
Appendix 1: CAM-ICU Confusion Assessment Score 
Appendix 2: MRC Score 
Appendix 3: Modified Cowling Swallowing Score 
Appendix 4: Bronchial fibroscopy procedure 
Appendix 5: Lung ultrasound procedure 
Appendix 6: Lung ventilation score 
Appendix 7: Lung ultrasound report 
Appendix 8: Ultrasound of the diaphragm 
Appendix 9: Patient information note 
Appendix 10: Tutor/Proxy briefing note 
Appendix 11: Background note to the research process 
 
 

DESCATRON V3.0 du 14/01/2021 
15.1 Appendix 1: CAM-ICU Confusion Assessment Score (26) 
 
The score can only be used in patients who are able to open their eyes and shake hands on 
demand. 
 
Criterion 1: Sudden onset and fluctuating course 
Is the change in the patient's mental state sudden? (yes=positive/no=negative) 
Are there any fluctuations over the last 24 hours? (yes=positive/no=negative) 
 
Criterion 2: Inattention 
Does the patient have difficulty focusing attention? 
ABRACADABRA" test: spell out each letter (1-2 seconds between each letter) and ask the 
patient to shake hands on the letter "A": 
The test is positive if there are more than two errors (either the patient does not serve the hand 
on the letter A or serves it on another letter) 
 
Criterion 3: Disorganised thinking 
 
YES/NO question 
o Does a stone float? 
o Are there fish in the sea? 
o Does one kilogram weigh more than two kilograms? 
The test is positive if there is more than one wrong answer 
 
 
Verbal orders 
o Tell the patient: "Show me the same number of fingers" (Show two fingers) 
o Then "Do the same with the other hand". 
The test is positive if the patient is wrong in these two commands 
 
Criterion 4: Vigilance Assessment 
Overall, how would you rate your patient's general condition? 
Alert, Vigilant, Lethargic, Stuporous, Comatose 
The test is positive if the level of awareness is other than alert 
 
The diagnosis of delirium requires the presence of 3 of the 4 criteria. Criteria 1 and 2 are always 
required, together with criteria 3 or 4. 
 

DESCATRON V3.0 du 14/01/2021 
15.2 Appendix 2: MRC Score (28) 
 
 
Score assigned to each muscle group : 
 
0 = no visible contraction 
 
1 = visible contractions without limb movement 
 
2 = insufficient movement to overcome weightlessness 
 
3 = movements to overcome weightlessness 
 
4 = movements against weightlessness and resistance 
 
5 = normal muscle strength 
 
RIGHT 
Function 
LEFT 
 
 
 
 
 
Shoulder abduction 
 
 
 
 
 
 
 
 
 
 
Elbow flexion 
 
 
 
 
 
 
 
 
 
 
Wrist extension 
 
 
 
 
 
 
 
 
 
 
Subtotal upper limbs 
(/15) 
 
 
 
 
 
 
 
 
 
 
Hip flexion 
 
 
 
 
 
 
 
 
 
 
Knee extension 
 
 
 
 
 
 
 
 
 
 
Ankle dorsal flexion 
 
 
 
 
 
 
 
 
 
 
Subtotal lower limbs 
(/15) 
 
 
 
 
 
 
 
 
 
 
SCORE 
 
 
 
 
 
Date: ..../..../.... ..../60 
Date: ..../..../.... ..../60 
Date: ..../..../.... ..../60 
Date: ..../..../.... ..../60 
Date: ..../..../.... ..../60 

DESCATRON V3.0 du 14/01/2021 
15.3 Appendix 3: Modified Cowling Swallowing Score (18) 
 
Cowling swallowing and dysphagia assessment score from the Knyrim score (27) 
 
 
0 = no anomaly 
 
1 = solids anomaly 
 
2 = liquid anomaly 
 
3 = liquid and solid anomaly 
 
 
 

DESCATRON V3.0 du 14/01/2021 
15.4 Appendix 4: Procedure for decanulation bronchial fibroscopy 
Material 
A flexible bronchial fiberscope is very suitable. 
 
 
Examination procedures 
The examination is performed under local anaesthesia of the nasal cavity with lidocaine spray 
and application of lidocaine gel on the fiberscope to allow painless penetration and progression 
through the nasal cavity. 
 
The patient is placed in a semi-seated position with spirometry monitoring and oxygen therapy 
if required. 
The endoscopic airway examination begins with the exploration of the pharynx, hypopharynx 
and larynx. The elements visualised are: the ENT sphere as a whole, the epiglottis, the 
valleculae, the arytenoids, the vocal cords, the piriform sinuses and the position of the 
nasogastric tube in the latter.  
Sensitivity analysis is also tested. 
The analysis continues with subglottic exploration with crossing of the vocal cords, 
visualization of the trachea, placement of the tracheostomy cannula and visualization of the 
underlying airway. 
 
Several lesions are looked for: laryngeal and/or pharyngeal oedema, granuloma, tracheal ring 
fracture, inflammation, uni/bilateral vocal cord paralysis, uni/bilateral arytenoid paralysis, 
granuloma, tracheal stenosis, tracheomalacia or cannula malposition. 
 

DESCATRON V3.0 du 14/01/2021 
15.5 Appendix 5: Procedure for lung ultrasound 
 
Materials 
In thoracic ultrasound, a simple device is quite suitable. More sophisticated equipment offers 
filters to manage artefacts: since lung ultrasound is based on the analysis of artefacts linked 
to the presence of air, it is obvious that they should be avoided. Two types of probe are used: 
the convex probe, low frequency, which allows exploration of the thoracic compartment in 
depth (e.g.: pulmonary parenchyma) and the linear probe, high frequency, which allows 
exploration of superficial structures (e.g.: pleura). The linear probe will be preferentially used, 
except for the exploration of consolidations or effusions. 
 
Thoracic topography 
The lung is a large organ, so it is 
necessary to specify the thoracic regions 
to be examined (Figure A): the axillary 
space is delimited by an anterior axillary 
line (AAL) and a posterior axillary line 
(PAL). These define an anterior region of 
exploration, bounded medially by the 
parasternal line (PSL), a lateral region, 
bounded by the anterior and posterior 
axillary lines, and a posterior region, 
bounded medially by the posterior axillary 
line and medially by the mid-scapular or 
paravertebral line. Each region is divided 
into an upper and lower part. Four levels 
of investigation are possible, depending 
on what the examiner is looking for 
(Figure 
B). 
For 
a 
conventional 
examination, the first three levels are used and each hemithorax thus comprises six regions to 
be explored. 
 
Examination procedures 
The patient is placed in a semi-seated position (30° inclination). The patient may be positioned 
slightly to the side for exploration of the posterior regions (examination level 3). 

DESCATRON V3.0 du 14/01/2021 
The location of the liver on the right and the spleen on the left identifies the diaphragm, 
separating the thoracic compartment from the abdominal compartment. 
  
The ultrasound probe is placed in an intercostal space along a horizontal axis (minor axis), 
providing a transverse view (Figure B). Each intercostal space of the different regions is thus 
explored by moving the probe transversely, from the inside to the outside. 
Assessment of lung ventilation 
Exploration of the 12 thoracic regions allows a global assessment of pulmonary aeration. Four 
levels of ventilation are defined (Figure below): 
 
Normal ventilation (N): presence of pleural slip and A-lines and less than two isolated 
B-lines; 
 
Moderate loss of ventilation (B1): presence of multiple, well-defined B-lines (at least 3); 
 
Severe loss of aeration (B2): presence of coalescing B-lines; 
 
Lung consolidation (C). 
 
 
Normal ventilation 
 
 
B lines (B1) 
 
 
Consolidation 

DESCATRON V3.0 du 14/01/2021 
15.6 Appendix 6: Ultrasound Lung Aeration Score (29) 
 
Exploration of the 12 thoracic regions allows a global assessment of pulmonary aeration. Four levels 
of ventilation are defined (30) : 
 
 
Normal ventilation (N): presence of pleural slip and A-lines and less than two isolated B-lines; 
 
Moderate loss of ventilation (B1): presence of multiple, well-defined B-lines (at least 3); 
 
Severe loss of aeration (B2): presence of coalescing B-lines; 
 
Lung consolidation (C). 
 
A global score can be calculated: N=0, B1=1, B2=2, C=3, for each of the thoracic regions, i.e. a total 
score out of 36. 
 
  
 
 

DESCATRON V3.0 du 14/01/2021 
15.7 Appendix 7: Lung ultrasound report 
 
 
 
FAN PARAMETERS (circle mode and fill in parameters at time of review) 
Mode 
VAC 
CAVI 
PC 
VSAI 
NIV 
Spontaneous 
breathing 
Paramete
rs 
Tidal volume = PEP = 
AI = PEP = 
 
 
LUNG VENTILATION 
 
 
LAT 
ANT 
ANT 
LAT 
 
 
Superior 
POST 
 
 
 
 
POST 
Superior 
Lower
 
 
 
 
 
 
Lower 
Indicate the ventilation level (0, 1, 2, 3) on the above diagram 
LUS score = /36 
If there is a consolidation, indicate the corresponding letter(s) (on the diagram and following the "3"): 
a. 
Deep ripped-looking border 
b. 
Deep edge with a smooth 
appearance 
c. 
Dynamic aeriform 
bronchogram 
d. 
Static aeriform bronchogram 
e. 
Aeriform punctiform 
bronchogram 
f. 
Aeriform thread-like 
bronchogram 
g. 
Fluid bronchogram 
h. 
Vascular pattern 
i. 
Shunt (Doppler) 
j. 
Subpleural consolidations 
Specify the presence of a pleural effusion and its location by annotating EP 
+ A (anechoic) or Heter (heterogeneous complex) or Homo (homogeneous complex) or C (partitioned) and PLD 
 
DISTRIBUTION OF VENTILATION DISORDERS 
Homogenous 
 
Heterogeneous 
Focus 
 
Diffuse 
 
 
DIAPHRAGM
 
Right 
Left 
tdi/tde (cm) 
 
 
 
 
DTF (%) 
 
 
EXC (cm) 
 
 
 
TO BE FILLED IN 
 
Quality of the review : 
Good 
Wrong 
 
Operator : 
 
 
Signature of the referring ultrasound physician: 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 
Pleural line 
irregular 

DESCATRON V3.0 du 14/01/2021 
15.8 Appendix 8: Diaphragmatic ultrasound 
 
When assessing the diaphragm in mechanically ventilated patients, and if the patient's respiratory 
status permits, the ventilator parameters are changed by the physician: AI = 7 cmH20 and PEEP = 0 
cmH20, to reflect spontaneous ventilation conditions. 
 
 
Diaphragm excursion: anterior subcostal route: The convex probe is placed in the anterior subcostal 
route, between the anterior axillary line and the mid-clavicular line: B mode is initially used to obtain 
the best visual approach. After this identification, the measurement of the diaphragm excursion is 
carried out in TM mode: during inspiration the diaphragm moves towards the probe and away from 
it during expiration. The excursion is equal to the distance measured between inspiration and 
expiration (maximum effort required from the patient). An excursion < 2.5 cm (LerolleChest, 2009) 
indicates a diaphragm dysfunction. 
 
 
 
 
Thickening of the diaphragm: Examination modalities: The probe is placed in an intercostal space, 
between the median and anterior axillary line, 0.5cm to 2cm below the costophrenic sinus. In B-
mode, the diaphragm appears as a hypoechoic structure between two hyperechoic layers: the pleura 
(outer layer) and the peritoneum (inner layer). The thickening fraction (TF) is measured in B mode 
according to the following formula: TF (%) = [(end-inspiratory thickness - end-expiratory thickness)/ 
end-expiratory thickness] x 100. The patient is asked to perform maximum inspiration and expiration. 
A TF < 25% indicates diaphragm dysfunction. 
 
 
 

DESCATRON V3.0 du 14/01/2021 
15.9 Appendix 9: Patient information note 
 
DARC VADOC 
"Study of the determinants of successful decanulation in 
tracheostomized patients in the post-resuscitation rehabilitation 
ward. A cohort study". 
 
RCB ID: 2020-A02942-37 
 
PRINCIPAL INVESTIGATOR 
Dr Jean-Baptiste PERETOUT, intensive care physician 
Forcilles Hospital 
USIR-SRPR service 
Route de Servon 77150 Férolles-Attilly 
Email : nbourry@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Commission 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.61.31 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Madam, Sir, 
Dr. ..............................................., investigator of the study, working in the Post-Resuscitation 
Rehabilitation Department of the Forcilles-Fondation Cognacq-Jay Hospital, invites you to 
participate in this research. 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are admitted to the post-resuscitation rehabilitation department following an inpatient stay 
in intensive care for severe respiratory disease. Your respiratory condition has required a 
tracheotomy to continue weaning from artificial ventilation. 
 
 

DESCATRON V3.0 du 14/01/2021 
What is the purpose of this research? 
The aim of this research is to determine the factors for successful decanulation, i.e. removal 
of the cannula inserted in the trachea and connected to the ventilator, of tracheostomised 
patients in order to select and optimise the management of these patients. 
How does this research work? 
As part of the rehabilitation you will receive in the department, we propose to study your 
respiratory function by performing a lung and diaphragm ultrasound.  
The ultrasound examination is painless, non-invasive and risk-free. It is carried out by the 
physiotherapist or doctor, using the ultrasound machine, an ultrasound probe and jelly water.  
The ultrasound will be performed once, when you are first admitted to the intensive care unit, 
and will last about 30 minutes. 
Your constraints in this research? 
The constraints of this research consist of 1 ultrasound scan of the thorax, lasting a maximum 
of 30 minutes. 
 
Possible adverse effects 
As your participation in this protocol does not involve any administration of treatment other 
than what is currently recommended or any other changes to the conventional management 
of the patient in the ICU, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
The ultrasound will be performed transthoracically, i.e. by placing the probe on your chest. 
The examination is therefore non-invasive, completely painless and does not involve exposure 
to X-rays. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
What are the expected benefits of this research? 
This study should improve our knowledge of the factors involved in successful ventilatory 
weaning of tracheostomised patients. This will provide information on the elements involved in 
the success of decanulation in order to better adapt the therapeutic approach. 
 
What are the conditions for participating in this study? 
In order to participate in this research, you must be affiliated to or benefit from a social security 
scheme. However, your participation in this research will not result in any additional costs for 
you compared to those incurred in the usual care. 

DESCATRON V3.0 du 14/01/2021 
 
Number of patients planned and duration of research? 
This research will last 25 months with a 24 month recruitment period to include 100 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, ventilator settings, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, speech therapists). No 
information bearing your name will be provided to anyone except the doctor in charge of the 
study and authorised personnel. All data collected will be confidential and coded and analysed 
by the Clinical Research Commission of the Forcilles-Fondation Cognacq-Jay Hospital, the 
research sponsor. The identification list (correspondence between your code for the study and 
your identity) will be kept strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 
The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your participation in this research is entirely free and voluntary. You have the right not to 
participate in this research. 
You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the Public Health Code, the entire research file 
has been submitted to the Comité de Protection des Personnes, CPP Ile de France 2, which 
issued a favourable opinion on xx/xx/xxxx. 

DESCATRON V3.0 du 14/01/2021 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop participating in the research at any time without justification. This will not affect 
the quality of the care and treatment provided to you or your relationship with your doctor. The 
data collected until you withdraw your consent will be used unless you expressly request it. 
Indeed, in accordance with Article 17 of the GDPR, you have the right to request the deletion 
of your data already collected. The withdrawal of your consent and the agreement to use or 
not your previously collected data will be traced in your medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 April 
2016 (General Data Protection Regulation), you have a right of access, rectification, erasure 
or restriction of processing. You can find out more about your rights by visiting the CNIL 
website 
https://www.cnil.fr/fr/reglement-europeen-protection-donnees/chapitre3. 
In 
accordance with the provisions of Article 21 of the RGPD, you also have the right to object to 
the transmission of data likely to be used in the context of this research and to be processed. 
Your request must be addressed to the Data Protection Officer of the Cognacq-Jay 
Foundation, either by e-mail to dpo@cognacq-jay.fr or by post to the address: Hôpital Forcilles-
Fondation Cognacq-Jay, Délégué à la Protection des Données, route de Servon 77150 
Férolles-Attilly. You also have the right to lodge a complaint with the Commission Nationale de 
l'Informatique et des Libertés - CNIL (French personal data control authority, website: 
www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you decide to 
participate in this research, the research information and your oral consent will be notified and 
dated in your medical file. 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 

DESCATRON V3.0 du 14/01/2021 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 
 
 

DESCATRON V3.0 du 14/01/2021 
15.10 Appendix 10: Information note to the relative 
 
DARC VADOC 
"Study of the determinants of successful decanulation in 
tracheostomized patients in the post-resuscitation rehabilitation 
ward. A cohort study". 
 
RCB ID: 2020-A02942-37 
 
PRINCIPAL INVESTIGATOR 
Dr Jean-Baptiste PERETOUT, intensive care physician 
Forcilles Hospital 
USIR-SRPR service 
Route de Servon 77150 Férolles-Attilly 
Email : nbourry@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Commission 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.61.31 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
 
Due to his condition which makes him unable to receive and understand the information that 
will be given to him, we are transmitting to you the information and the proposal of participation 
of Mr, Mrs, Mr (delete as appropriate) (name, first name)......................................... in the study 
presented below, under the responsibility of Dr ............................................., the investigator 
of the study. 
 
Your opinion on this participation is entirely free and voluntary. 
 
Please read the information below carefully, ask any questions you may have, and take as 
much time as you wish to reflect on your decision as to whether or not your loved one should 
participate in this research. 
 
 

DESCATRON V3.0 du 14/01/2021 
 
ATTENTION 
You can only give your consent : 
- if you and the patient you are caring for are not legally deprived of your right to give 
such consent; 
- whether the patient you are caring for is covered by social security; 
- if you consider that your decision would probably be that of the patient you are caring 
for; 
- if you feel fully informed; 
- if you were able to ask the doctor in charge of the study all the questions you wanted 
to ask about the research and the way it was going to be carried out and if you consider 
that you were given satisfactory answers (if, during the study, you have new questions, you 
can ask them to the doctor in charge of the study, in particular if they concern the interest of 
the study, the ratio of benefits and risks or the usefulness of collecting certain data from your 
family member) ; 
- if you feel free to give your consent to such participation; 
- if you accept that the patient you are caring for may not agree with you and when they 
get better and are consulted again, do not give consent to continue their participation. 
Even if you give your consent today, you may withdraw it at any time and study-related 
interventions will be stopped as quickly as possible so that no harm is done to the 
patient. The relationship and quality of current or future care that the patient will receive 
will not be changed in any way should this occur. The information collected previously 
to this stop will be used unless you do not want it to be used. You should then inform 
the patient's doctor who will suggest appropriate medical follow-up. 
 
Your relative is in a post-resuscitation rehabilitation unit following an in-patient stay in intensive 
care for severe respiratory disease. His or her respiratory condition has required a tracheotomy 
to continue weaning from artificial ventilation. 
 
 

DESCATRON V3.0 du 14/01/2021 
What is the purpose of this research? 
The aim of this research is to determine the factors for successful decanulation, i.e. removal 
of the cannula inserted in the trachea and connected to the ventilator, of tracheostomised 
patients in order to select and optimise the management of these patients. 
How does this research work? 
As part of the rehabilitation your relative will receive in the department, we propose to study 
his or her respiratory function by performing a lung and diaphragm ultrasound.  
The ultrasound examination is painless, non-invasive and risk-free. It is carried out by the 
physiotherapist or doctor, using the ultrasound machine, an ultrasound probe and jelly water.  
The ultrasound will be performed once, during his initial admission to the post-resuscitation 
rehabilitation department and will last about 30 minutes. 
What are the constraints for your family member in this search? 
The constraints of this research consist of 1 ultrasound scan of the thorax, lasting a maximum 
of 30 minutes. 
 
Possible adverse effects 
As participation in this protocol does not involve any administration of treatment other than 
what is currently recommended or any other changes to the conventional management of the 
post-resuscitation patient, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
The ultrasound will be performed transthoracically, i.e. by placing the probe on the chest of 
your loved one. The examination is therefore non-invasive, completely painless and does not 
involve exposure to X-rays. 
Your loved one's participation in this research will not result in any additional costs compared 
to those that would have been incurred in the usual follow-up of their illness. 
What are the expected benefits of this research? 
This study should improve our knowledge of the factors involved in successful ventilatory 
weaning of tracheostomised patients. This will provide information on the elements involved in 
the success of decanulation in order to better adapt the therapeutic approach. 
 
What are the conditions for participating in this study? 
In order to participate in this research, your relative must be affiliated to or benefit from a social 
security scheme. However, participation in this research will not result in any additional costs 
for your relative compared to those incurred in the usual care. 

DESCATRON V3.0 du 14/01/2021 
 
Number of patients planned and duration of research? 
This research will last 25 months with a 24 month recruitment period to include 100 patients. 
 
What data is collected for the research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, ventilator settings, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, speech therapists). No 
information bearing your relative's name will be provided to anyone except the doctor in charge 
of the study and authorised personnel. All data collected will be confidential and coded and 
analysed by the Clinical Research Commission of the Forcilles-Fondation Cognacq-Jay 
Hospital, the promoter of the research. The identification list (correspondence between your 
code for the study and your identity) will be kept strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 
The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your relative's participation in this research is entirely free and voluntary. Your relative's 
doctor must provide you with all the necessary explanations concerning this research, which 
must comply with the provisions of Article 13 of European Regulation No. 2016/679 (General 
Data Protection Regulation, GDPR). In accordance with article L.1122-1 of the Public Health 
Code, the entire research file has been submitted to the Comité de Protection des Personnes, 
CPP Ile de France 2, which issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop your participation in the research at any time without justification. This will not 
affect the quality of the care and treatment provided to your relative or his or her relationship 

DESCATRON V3.0 du 14/01/2021 
with the doctor. The data collected until the withdrawal of consent will be used unless you 
expressly request it. Indeed, in accordance with Article 17 of the GDPR, your relative has the 
right to request the deletion of your data already collected. The withdrawal of his or her consent 
and the agreement to use or not use his or her previously collected data will be traced in your 
medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 April 
2016 (General Data Protection Regulation), your loved one has a right of access, rectification, 
erasure or restriction of processing. You can find out more about your loved one's rights by 
visiting 
the 
CNIL 
website 
https://www.cnil.fr/fr/reglement-europeen-protection-
donnees/chapitre3. In accordance with the provisions of Article 21 of the RGPD, your relative 
also has the right to object to the transmission of data that may be used in the context of this 
research and to be processed. His/her request must be addressed to the Data Protection 
Officer of the Cognacq-Jay Foundation, either by e-mail to dpo@cognacq-jay.fr, or by post to 
the address: Hôpital Forcilles-Fondation Cognacq-Jay, Délégué à la Protection des Données, 
route de Servon 77150 Férolles-Attilly. The user also has the right to lodge a complaint with 
the Commission Nationale de l'Informatique et des Libertés - CNIL (French authority for the 
control of personal data, website: www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, your relative may 
also access all medical data concerning him or her directly or through a doctor of his or her 
choice. 
Your relative's medical file will remain confidential and can only be consulted under the 
responsibility of the doctor in charge of your treatment, as well as by the health authorities and 
by persons duly mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and 
subject to professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you agree to your 
relative taking part in this research, the information about the research and your oral consent 
will be notified and dated in your medical file. 
 
 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 

DESCATRON V3.0 du 14/01/2021 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research. 
 
 

DESCATRON V3.0 du 14/01/2021 
15.11 Appendix 11: Patient information note for further research 
 
DARC VADOC 
"Study of the determinants of successful decanulation in 
tracheostomized patients in the post-resuscitation rehabilitation 
ward. A cohort study". 
 
RCB ID: 2020-A02942-37 
 
PRINCIPAL INVESTIGATOR 
Dr Jean-Baptiste PERETOUT, intensive care physician 
Forcilles Hospital 
USIR-SRPR service 
Route de Servon 77150 Férolles-Attilly 
Email : nbourry@cognacq-jay.fr  
 
RESEARCH PROMOTER 
Clinical Research Commission 
Forcilles Hospital-Cognacq-Jay Foundation 
Route de Servon 77150 Férolles-Attilly 
Telephone: 01.60.64.61.31 
Fax: 01.60.02.15.09 
aleneindre@cognacq-jay.fr 
 
Dear Sir or Madam, 
Due to the severity of your condition, we were unable to ask for your prior consent and you 
were included on ........../.........../........... in a research study entitled DESCATRON. 
In accordance with the law (article L.1122-1-3 of the Public Health Code), the trusted person 
you have designated or your parent/relative has been asked to agree to your participation in 
this research. 
Now that you are able to understand and express your wishes, we ask for your consent to 
continue your participation in this research. 
The doctor told you that you were free to accept or refuse further participation in this research. 
 
 
 

DESCATRON V3.0 du 14/01/2021 
Your decision to participate is entirely free and voluntary. 
Please read the information below carefully, ask any questions you may have and take as 
much time as you wish to reflect on your decision to participate in this research. 
You are admitted to the post-resuscitation rehabilitation department following an inpatient stay 
in intensive care for severe respiratory disease. Your respiratory condition has required a 
tracheotomy to continue weaning from artificial ventilation. 
What is the purpose of this research? 
The aim of this research is to determine the factors for successful decanulation, i.e. removal 
of the cannula inserted in the trachea and connected to the ventilator, of tracheostomised 
patients in order to select and optimise the management of these patients. 
How does this research work? 
As part of the rehabilitation you will receive in the department, we propose to study your 
respiratory function by performing a lung and diaphragm ultrasound.  
The ultrasound examination is painless, non-invasive and risk-free. It is carried out by the 
physiotherapist or doctor, using the ultrasound machine, an ultrasound probe and jelly water.  
The ultrasound will be performed once, when you are first admitted to the intensive care unit, 
and will last about 30 minutes. 
Your constraints in this research? 
The constraints of this research consist of 1 ultrasound scan of the thorax, lasting a maximum 
of 30 minutes. 
 
Possible adverse effects 
As your participation in this protocol does not involve the administration of any treatment other 
than that which is currently recommended or any other changes to the conventional 
management of the patient in the ICU, no adverse effects are expected. 
- 
No additional treatment will be administered 
- 
No additional blood tests will be required. 
The ultrasound will be performed transthoracically, i.e. by placing the probe on your chest. 
The examination is therefore non-invasive, completely painless and does not involve exposure 
to X-rays. 
Your participation in this research will not incur any additional costs compared to those you 
would have had in the usual follow-up of your disease. 
What are the expected benefits of this research? 

DESCATRON V3.0 du 14/01/2021 
This study should improve our knowledge of the factors involved in successful ventilatory 
weaning of tracheostomised patients. This will provide information on the elements involved in 
the success of decanulation in order to better adapt the therapeutic approach. 
What are the conditions for participating in this study? 
In order to participate in this research, you must be affiliated to or benefit from a social security 
scheme. However, your participation in this research will not result in any additional costs for 
you compared to those incurred in the usual care. 
 
Number of patients planned and duration of research? 
This research will last 25 months with a 24-month recruitment period to include 100 patients. 
 
What data is collected for research? 
The medical data collected during this study will be processed in a computerised, coded and 
confidential manner. The main data collected will be anthropometric data (age, weight, height, 
etc.), related to medical history, ventilator settings, biological check-ups, and the results of 
check-ups by rehabilitation professionals (physiotherapists, dieticians, speech therapists). 
No information bearing your name will be provided to anyone except the doctor in charge of 
the study and authorized personnel. All data collected will be confidential and coded and 
analysed within the Clinical Research Commission of the Forcilles-Fondation Cognacq-Jay 
Hospital, promoter of the research. The identification list (correspondence between your code 
for the study and your identity) will be kept strictly confidential. 
In accordance with the regulations in force, the data will be kept until the final research report 
is produced and then archived for 15 years. 
The data controller is the promoter, Hôpital Forcilles-Fondation Cognacq-Jay, route de Servon 
77150 Férolles-Attilly. 
 
Legal basis for data processing 
The processing of the data is based on the legitimate interests of the controller, Article 6 
paragraph 1 point f, read in conjunction with the necessity of the processing for scientific 
research purposes, Article 9 paragraph 2 point j, of the European Regulation N° 2016/679 
(General Data Protection Regulation, GDPR). 
 
What are your rights? 
Your participation in this research is entirely free and voluntary. You have the right not to 
participate in this research. 

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You cannot be included in an interventional research protocol with minimal risks and 
constraints without having been informed beforehand. Your doctor must provide you with all 
the necessary explanations concerning this research, which must comply with the provisions 
of Article 13 of European Regulation No. 2016/679 (General Data Protection Regulation, 
GDPR). In accordance with article L.1122-1 of the Public Health Code, the entire research file 
has been submitted to the Comité de Protection des Personnes, CPP Ile de France 2, which 
issued a favourable opinion on xx/xx/xxxx. 
The Forcilles-Fondation Cognacq-Jay hospital has taken out insurance under contract no. 
163607 guaranteeing its civil liability and that of all those involved with the company SHAM. 
You can stop participating in the research at any time without justification. This will not affect 
the quality of the care and treatment provided to you or your relationship with your doctor. The 
data collected until you withdraw your consent will be used unless you expressly request it. 
Indeed, in accordance with Article 17 of the GDPR, you have the right to request the deletion 
of your data already collected. The withdrawal of your consent and the agreement to use or 
not your previously collected data will be traced in your medical file. 
 
In accordance with the provisions of Articles 15 and 16 of Regulation (EU) 2016/679 of 27 April 
2016 (General Data Protection Regulation), you have a right of access, rectification, erasure 
or restriction of processing. You can find out more about your rights by visiting the CNIL 
website 
https://www.cnil.fr/fr/reglement-europeen-protection-donnees/chapitre3. 
In 
accordance with the provisions of Article 21 of the RGPD, you also have the right to object to 
the transmission of data likely to be used in the context of this research and to be processed. 
Your request must be addressed to the Data Protection Officer of the Cognacq-Jay 
Foundation, either by e-mail to dpo@cognacq-jay.fr or by post to the address: Hôpital Forcilles-
Fondation Cognacq-Jay, Délégué à la Protection des Données, route de Servon 77150 
Férolles-Attilly. You also have the right to lodge a complaint with the Commission Nationale de 
l'Informatique et des Libertés - CNIL (French personal data control authority, website: 
www.cnil.fr). 
In application of the provisions of article L. 1111-7 of the Public Health Code, you may also 
access all of your medical data directly or through a doctor of your choice. 
Your medical file will remain confidential and can only be consulted under the responsibility of 
the doctor in charge of your treatment, as well as by the health authorities and by persons duly 
mandated by the Forcilles-Fondation Cognacq-Jay hospital for research and subject to 
professional secrecy. 
If, after having read all this information and discussed all aspects with the doctor in charge of 
the research, you have had sufficient time to reflect on your decision and you decide to 

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participate in this research, the research information and your oral consent will be notified and 
dated in your medical file. 
 
The agreement to participate in this research is free and voluntary. 
You may refuse or withdraw your consent at any time without explanation or prejudice. 
 
Any questions? 
 
Dr. ________________________ (tel. ______________________) is at your disposal for any 
further information you may require before and during the research.