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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
425
No aspiration within the 3 minutes before extubation and extubation with 10cmH2O PEEP
Aspiration during cuff deflation
CHU Orléans
Orléans, Orléans, France
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 La Miletrie
Poitiers, France
...and 1 more locations
Ventilator free days at the 28th day
The primary endpoint is the number of mechanical ventilation-free days (invasive and non-invasive) after the first extubation procedure
Time frame: From DZéro to D27
Re-intubation rate
The re-intubation rate (%) within seven days following the removal of the Extubation Procedure
Time frame: 7 days (from Dzéro to D6)
Cumulated duration of non invasive ventilation (NIV) and High flow oxygenation (HFO)
Duration marked in hours , same for NIV and HFO
Time frame: 7 days (from Dzéro to D6)
Proportion of patients with pneumonia and/or atelectasis
radiological assessment of pneumonia and/or atelectasis. A systematic chest radiography is to be done at 72 hours and 7 days after extubation procedure.
Time frame: within 72 hours ( D2) and within 7 days ( D6)
Rate of Respiratory acute failure (RAF)
Percentage of included patients who with clinical RAF after extubation procedure
Time frame: Within 7 days (from Dzéro to D6)
Lenght of stay in Intensive care unit (ICU) and in hospital
Marked in days.
Time frame: within 28 days
Rate of death
Whatever the cause of death for included patients
Time frame: Within 28 days (from Dzero to Day 27)
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