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

Not Applicable

• Conditions: Patients Undergoing Digestive Surgery With Orotracheal Intubation

• Registration Number: NCT04381949
• Lead Sponsor: University Hospital, Rouen

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Last Update Submitted: 2020-05-06
• Study First Posted: 2020-05-11
• Last Update Posted: 2020-05-11
• Study Start: 2020-06-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Desaturation rate	within one hour of tracheal extubation	defined by a SpO2 \< 92%