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

NCT ID: NCT04381949

Last Updated: 2020-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-06-01

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

Patients Undergoing Digestive Surgery With Orotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard extubation Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Positive pressure extubation arm

Group Type: EXPERIMENTAL

positive pressure extubation

Intervention Type: 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"

Interventions

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"

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2019/0351/HP

Identifier Type: -

Identifier Source: org_study_id