EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
Extubation in intensive care unit is a risky situation. Its failure is associated with an increase in the duration of mechanical ventilation and high morbidity and mortality. Our hypothesis is that the extubation procedure associating prior endotracheal aspiration followed by ablation of the intubation probe under the application of a PEEP, would make it possible both to avoid the leakage of secretions towards the lower airways and the alveolar recruitment, compared to extubation with concomitant endotracheal aspiration. By these mechanisms, this extubation procedure combining prior endotracheal aspiration followed by ablation of the tube under the application of a PEEP, would make it possible to increase the ventilator free days from any mechanical ventilation.

Detailed Description
-----------------
Extubation consists of several distinct phases: obtaining the weaning criteria, succeeding weaning test and then removing the intubation tube. While the first two stages are the subject of numerous publications, the last one is rarely studied. To reduce the risk of failure of extubation, the scientific societies of intensive care medicine have published recommendations. They relate to patient weaning and weaning testing, but there are no clear recommendations for the procedure for removing the intubation tube. The ablation of the tube, performed by the chest physiotherapist or nurse, typically involves endotracheal aspiration, from deflation of the cuff to removal of the intubation tube. The objective is theoretically to prevent the secretions accumulated above the cuff, at the pharyngeal level, from falling into the lower airways. Laboratory data show that inhalation of secretions appears to be greater during ablation of the tube with concomitant endotracheal aspiration, which creates a reverse pressure gradient, propelling the secretions into the lower airways. The application of Positive Expiratory Pressure during the ablation of the tube would help to combat this phenomenon. At the same time, this Positive Expiratory Pressure could have a beneficial effect on alveolar recruitment. Recent work proves the non-inferiority of the ablation of the tube with the application of a Positive Expiratory Pressure versus the so-called reference method, consisting of endotracheal aspiration during the ablation of the tube. We wish to conduct a comparative, prospective, randomized, multicenter study comparing extubation with concomitant endotracheal aspiration versus ablation of the intubation tube under the application of a PEEP.

Official Title
-----------------
EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.

Conditions
-----------------
Extubation in Intensive Care Unit

Intervention / Treatment
-----------------
* Procedure: Extubation with PEEP
* Procedure: Endotracheal Aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICU Hospitalization Oro-tracheal intubation Mechanical ventilation for more than 24 h First extubation procedure within the stay in the inclusion unit Consent collected from a relative of the patient Non-Inclusion Criteria: Tracheostomy Neuro-muscular pre-existant disease or severe head injury Limitation of active therapeutics Inclusion in an other research interfering with our outcomes Non affiliated with an healthcare insurance Person benefiting from enhanced protection, namely minors, pregnant or nursing women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection (safeguard of justice, guardianship or curatorship) Exclusion Criteria: Impossibility of extubation considered by the clinician, on: Weanability criteria not met (including ineffective cough or significant bronchopulmonary congestion) Unsuccessful weaning test within 72 hours of close consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP Extubation With Positive End-Expiratory Pressure<br>endo-tracheal aspiration followed by the application of PEEP = 10 cm of H2O, maintained for 3 minutes (reventilation and rest time) and continued until the end of the procedure removal of the extubation | Procedure: Extubation with PEEP<br>* No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP<br>|
| Active Comparator: Aspiration Extubation With SUctioning<br>endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure | Procedure: Endotracheal Aspiration<br>* Aspiration during cuff deflation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days at the 28th day | Number of days, totally free of any type of mechanical ventilation (invasive ou non invasive) after the extubation procedure | From D day to 28th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intubation rate | Percentage of extubation failure needing re-intubation over all patients included | 3 days and 7 days | 
| Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO) | Duration marked in hours , same for NIV and HFO | within 7 days | 
| Proportion of patients with atelectasis | radiological assessment of atelectasis. A systematic chest radiography is to be done at 3 days and 7 days after extubation procedure. | within 7 days | 
| Rate of Respiratory acute failure (RAF) | Percentage of included patients who with clinical RAF after extubation procedure | Within 7 days | 
| Lenght of stay in Intensive care unit (ICU) and in hospital | Marked in days. | within 28 days | 
| Rate of death | Whatever the cause of death for included patients | Within 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
extubation, intensive care, endotracheal aspiration, positive end expiratory pressure, non invasive ventilation