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

Not Applicable

Completed

• Conditions: Extubation in Intensive Care Unit
• Interventions: Procedure: Extubation with PEEP; Procedure: Endotracheal Aspiration

• Registration Number: NCT05147636
• Lead Sponsor: Centre Hospitalier de Bourg en Bresse

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-07
• Study Start: 2023-03-22
• Status Verified: 2025-03
• Primary Completion: 2025-03-19
• Study Completion: 2025-03-19
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEEP Extubation With Positive End-Expiratory Pressure	Extubation with PEEP	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
Aspiration Extubation With SUctioning	Endotracheal Aspiration	endo-tracheal aspiration concomitant with removal of extubation. Suction is maintained throughout the intubation tube ablation procedure

Primary Outcome Measures

Name	Time	Method
Ventilator free days at the 28th day	From DZéro to D27	The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure

Secondary Outcome Measures

Name	Time	Method
Re-intubation rate	7 days (from Dzéro to D6)	The re-intubation rate (%) within seven days following the removal of the Extubation Procedure
Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)	7 days (from Dzéro to D6)	Duration marked in hours , same for NIV and HFO
Proportion of patients with pneumonia and/or atelectasis	within 72 hours ( D2) and within 7 days ( D6)	radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 72 hours and 7 days after extubation procedure.
Rate of Respiratory acute failure (RAF)	Within 7 days (from Dzéro to D6)	Percentage of included patients who with clinical RAF after extubation procedure
Lenght of stay in Intensive care unit (ICU) and in hospital	within 28 days	Marked in days.
Rate of death	Within 28 days (from Dzero to Day 27)	Whatever the cause of death for included patients

Trial Locations

Locations (11)

CH Annecy Genevois; 🇫🇷 Annecy, France

CH Victor Dupouy; 🇫🇷 Argenteuil, France

CH Bourg en Bresse; 🇫🇷 Bourg en Bresse, France

CHU Francois Mitterand; 🇫🇷 Dijon, France

CHU Michallon; 🇫🇷 Grenoble, France

HCL Croix Rousse; 🇫🇷 Lyon, France

HCL Edouard Herriot; 🇫🇷 Lyon, France

HCL Lyon Sud; 🇫🇷 Lyon, France

CHU Orléans; 🇫🇷 Orléans, France

CHU La Miletrie; 🇫🇷 Poitiers, France

Hopital Nord; 🇫🇷 Saint-Étienne, France