Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery

NCT04381949 | Completed

• 1 other identifier: 2019/0351/HP
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of a postoperative tracheal extubation protocol under positive pressure in accordance with international recommendations. Two arms: the first with "classic" extubation with disconnection of the respirator and the second with extubation without disconnection of the respiratory, as recommended. Computer Randomization with a 1: 1 ration

Conditions

Airway Management; Tracheal Extubation; Postoperative Respiratory Complications; Postoperative Hypoxemia; Atelectasis; General Anesthesia; Mechanical Ventilation

Keywords

Tracheal Extubation; Positive Pressure Extubation; Positive End-Expiratory Pressure (PEEP); Airway Management; Postoperative Desaturation; Postoperative Hypoxemia; Atelectasis; Mechanical Ventilation; General Anesthesia; Respiratory Complications; Post-Anesthesia Care Unit (PACU); Adult Surgery

Outcome Measures

Primary Outcomes (1)

• Desaturation rate

  defined by a SpO2 \< 92%

  within one hour of tracheal extubation

Study Arms (2)

Standard extubation Arm

NO INTERVENTION

Positive pressure extubation arm

EXPERIMENTAL

Procedure: positive pressure extubation

Interventions

positive pressure extubation PROCEDURE

Two arms: the first with "classic" extubation with disconnection of the ventilator and the second with an extubation without disconnection of the respiratory "positive pressure"

Positive pressure extubation arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\> 18 and \<80
• Patient going to benefit from general anesthesia with orotracheal intubation for surgery lasting more than 60 minutes at the visceral surgery unit of the Rouen University Hospital.
• Person affiliated to a social security scheme
• Person who has read and understood the newsletter and signed the consent form

You may not qualify if:

• Minor patients or age\> 80 years
• History of Obstructive Sleep Apnea Syndrome
• Chronic respiratory failure / History of chronic obstructive pulmonary disease
• Surgery \< 60 minutes
• Use of methylene blue intraoperatively
• Extubation finally performed in the operating room
• orotracheal intubation difficult to induce general anesthesia
• Suspected inhalation during orotracheal intubation
• Pneumothorax per operative
• Heart failure authenticated by trans thoracic ultrasound \<50%
• Neuromuscular pathologies (myasthenia gravis, myopathies)
• Body mass index\> 35
• Emergency surgery
• Patient with an ASA IV score (ie according to the definition of the American Society of Anesthesiology)
• Major surgical complications (hemorrhagic shock)

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Chu Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: August 3, 2022
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)