Removal of the Intubation Tube Under Positive Pressure With or Without Endotracheal Suctioning During Extubation in Intensive Care: a Prospective Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Respiratoy/oxygenation index (ROX index)
Study Overview
Brief Summary
The aim of this clinical trial is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
Detailed Description
This is a prospective, randomised, controlled trial. The aim of this study is to evaluate endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients (over 18 years old) in the intensive care unit (ICU). The main question it aims to answer is whether the intervention improves the respiratory oxygenation index (ROX) three hours after extubation compared to no endotracheal suction during positive pressure extubation.
Inclusion : Participants who meet eligibility criteria will be randomized into experimental arm (endotracheal suctioning during positive pressure extubation) or control arm (no endotracheal suction during positive pressure extubation).
Intervention and Follow-up : participants will only need to be extubated by the nursing team in the ICU. Follow-up will consist of evaluating respiratory rate, pulse oximetry and inspired oxygen fraction for three hours following extubation.
End of study : at the end of the study visit (28 days after extubation), vital status of participants will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient
- •Intubated for more than 48 hours
- •Patient for whom extubation is prescribed by the patient's physician
Exclusion Criteria
- •Headboard restriction>30°.
- •Decision to limit active treatment in advance of reintubation
- •Protected person (under guardianship or curatorship)
- •Person under court protection
- •Persons deprived of liberty
- •Persons not affiliated to a social security scheme
- •Pregnant or breast-feeding woman
- •No co-inclusion with a study whose period of interest is follow-up within 3 hours of extubation.
Arms & Interventions
Suctionning Extubation (experimental arm)
Endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
Intervention: Suctionning extubation (Procedure)
No Suctionning Extubation (control arm)
No endotracheal suctioning during positive pressure extubation in mechanically ventilated adult patients in the intensive care unit.
Intervention: No suctionning Extubation (Procedure)
Outcomes
Primary Outcomes
Respiratoy/oxygenation index (ROX index)
Time Frame: 3 hours after extubation
Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment)
Secondary Outcomes
- Airway clearance technique(During 24 hours after extubation)
- Mechanical ventilation weaning failure(During 7 days after extubation)
- ROX index evolution(During 3 hours after extubation)
- Pneumonia after extubation(During 7 days after extubation)