Does Positive Pressure Extubation Reduce Postoperative Desaturation?

Not Applicable

• Conditions: Extubation; Postoperative Complications; Lung Ultrasound Score
• Interventions: Procedure: positive pressure during extubation procedure

• Registration Number: NCT05295095
• Lead Sponsor: University Hospital, Lille

Brief Summary

Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Detailed Description

Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-24
• Study Start: 2022-06-29
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Visceral or urological surgery
• Scheduled surgery
• Surgical or patient requirement: placement of an arterial catheter
• Supine position
• Post-surgical extubation scheduled in the operating room
• Minimum age of 18 years
• Informed and signed consent

Exclusion Criteria

• Severe obesity (BMI over 35kg/m2)
• pregnant woman
• Acute or chronic preoperative respiratory pathology.
• Sleep apnea syndrome
• Inability to receive informed information (does not speak, read or understand French)
• Patient under guardianship or curatorship
• Lack of social security coverage
• History of intubation or criteria for difficult intubation or ventilation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VSPEP	positive pressure during extubation procedure	ETT was removed with APL valve set to 20cmH2O
VSAIPEP	positive pressure during extubation procedure	ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Primary Outcome Measures

Name	Time	Method
desaturations during extubation	1 minute after extubation	saturation \<92%

Secondary Outcome Measures

Name	Time	Method
desaturation postoperatory	5 and 30 minutes after extubation	saturation\<92%
atelectasis	30 minutes after extubation	Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome
feasibility and acceptance of both techniques pressure positive extubation	15 minutes after extubation	questionnaire, min = 4, max =20, higher scores mean is worse outcome
use of oxygen	day 7	days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation
hypoxemia post operatory	1 and 30 minutes after extubation	PaO2 \<60mmHg
awakening time	through extubation completion, an average 2 minutes	time in seconds
post operative complications	day 7 and day 28	Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France