Does Positive Pressure Extubation Reduce Postoperative Desaturation?

NCT05295095 | Completed

• 2 other identifiers: 2021_04332021-A03064-37
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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

Conditions

Extubation; Lung Ultrasound Score; Postoperative Complications

Keywords

positive pressure extubation; Postoperative Complications; lung ultrasound score

Outcome Measures

Primary Outcomes (1)

• desaturations during extubation

  saturation \<92%

  1 minute after extubation

Secondary Outcomes (7)

• desaturation postoperatory

  5 and 30 minutes after extubation

• hypoxemia post operatory

  1 and 30 minutes after extubation

• atelectasis

  30 minutes after extubation

• awakening time

  through extubation completion, an average 2 minutes

• use of oxygen

  day 7

Study Arms (3)

control group

NO INTERVENTION

Classical extubation technique : ETT was removed with continuous endotracheal suction

VSPEP

EXPERIMENTAL

ETT was removed with APL valve set to 20cmH2O

Procedure: positive pressure during extubation procedure

VSAIPEP

EXPERIMENTAL

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

Interventions

positive pressure during extubation procedure PROCEDURE

positive pressure during extubation procedure

VSAIPEP; VSPEP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cédric CIRENEI, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients under anaesthesia at randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 24, 2022
• Study Start: June 29, 2022
• Primary Completion: January 8, 2026
• Study Completion: February 19, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

FR (1)