Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study ExPress (ExPress)

Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study

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

Study Overview

• Status: Unknown
• Conditions: Patients Undergoing Digestive Surgery With Orotracheal Intubation
• Intervention / Treatment: Procedure: positive pressure extubation

• Study Type: Interventional
• Enrollment (Anticipated): 208
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Major anesthetic complications (anaphylactic shock, bronchospasm)
• Pregnant or parturient or lactating woman or woman of childbearing age without proven contraception
• Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard extubation Arm
Experimental: Positive pressure extubation arm	Procedure: positive pressure extubation; 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desaturation rate	defined by a SpO2 < 92%	within one hour of tracheal extubation

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019/0351/HP

Drug and device information, study documents

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