Extubation, Mechanical Ventilation With Oral Intubation, Oxygen Saturation Measurement, Rox Index, Weaning Invasive Mechanical Ventilation
Conditions
Keywords
rox index, extubation, Suctionning
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.
Interventions
PROCEDURESuctionning extubation
We will remove the intubation tube with endotracheal suctioning during the extubation procedure and maintain positive end expiratory pressure (PEEP) and pressure support. The PEEP level will be 10 cmH2O and the pressure support 7 cmH2O for 2 minutes prior to extubation. The vacuum level will be the maximum level (standard procedure in the unit), i.e. 450 mmHg. The closed-system suction probe is inserted up to the last mark corresponding to 40cm. The size of our closed system is identical for all patients, i.e. 14 french.
PROCEDURENo suctionning Extubation
In the control group, removal of the intubation tube during the extubation procedure is performed with PEEP maintained, without endotracheal suctioning. The PEEP level will be set at 10 cmH2O and the pressure at 7 cmH2O in the 2 minutes prior to extubation.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratoy/oxygenation index (ROX index) | 3 hours after extubation | Rox index will be assessed 3 hours after extubation by an investigator with no information about randomization (blind assessment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation weaning failure | During 7 days after extubation | Weaning failure corresponds with death or new intabution |
| ROX index evolution | During 3 hours after extubation | Rox index will be assessed 3 times after extubation in order to evaluate its evolution (blind assessment) : 1. 30 minutes after extubation 2. 1 hour after extubation 3. 3 hour after extubation |
| Pneumonia after extubation | During 7 days after extubation | Rate of hospital-acquired pneumonia confirmed by an investigator |
| Airway clearance technique | During 24 hours after extubation | Use of any airway clearance technique after extubation : * nasotracheal suction * respiratory physiotherapy * bronchial fibroscopy |
Countries
France
Contacts
Primary ContactCécile FOSSAT
Backup ContactFanny LOUAT
Outcome results
None listed