EXtubation With SUctioning or With Positive End-Expiratory Pressure in Intensive Care Unit: a Multicentre Randomised Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extubation in Intensive Care Unit
- Sponsor
- Centre Hospitalier de Bourg en Bresse
- Enrollment
- 425
- Locations
- 11
- Primary Endpoint
- Ventilator free days at the 28th day
- Status
- Completed
- Last Updated
- 4 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Ventilator free days at the 28th day
Time Frame: 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 Outcomes
- Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)(7 days (from Dzéro to D6))
- Re-intubation rate(7 days (from Dzéro to D6))
- Proportion of patients with pneumonia and/or atelectasis(within 72 hours ( D2) and within 7 days ( D6))
- Rate of Respiratory acute failure (RAF)(Within 7 days (from Dzéro to D6))
- Lenght of stay in Intensive care unit (ICU) and in hospital(within 28 days)
- Rate of death(Within 28 days (from Dzero to Day 27))