Does Positive Pressure Extubation Reduce Postoperative Desaturation? (EXTUBPOS)

The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery

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

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Extubation; Lung Ultrasound Score
• Intervention / Treatment: Procedure: positive pressure during extubation procedure

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 Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Claude Huriez Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Classical extubation technique : ETT was removed with continuous endotracheal suction
Experimental: VSPEP; ETT was removed with APL valve set to 20cmH2O	Procedure: positive pressure during extubation procedure; positive pressure during extubation procedure
Experimental: VSAIPEP; ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room	Procedure: positive pressure during extubation procedure; positive pressure during extubation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
desaturations during extubation	saturation <92%	1 minute after extubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Cédric CIRENEI, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2022
• Primary Completion (Actual): January 8, 2026
• Study Completion (Actual): February 19, 2026

Study Registration Dates

• First Submitted: February 21, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Complications; lung ultrasound score; positive pressure extubation
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 2021_0433; 2021-A03064-37 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No