Endotracheal Suctionning During Positive Pressure Extubation in ICU

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation With Oral Intubation; Weaning Invasive Mechanical Ventilation; Oxygen Saturation Measurement; Rox Index; Extubation

• Registration Number: NCT07130123
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-01
• Primary Completion: 2027-09
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mechanical ventilation weaning failure	During 7 days after extubation	Weaning failure corresponds with death or new intabution
Airway clearance technique	During 24 hours after extubation	Use of any airway clearance technique after extubation : * nasotracheal suction; * respiratory physiotherapy; * bronchial fibroscopy
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Orléans; 🇫🇷 Orléans, Loiret, France