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

Patients Undergoing Digestive Surgery With Orotracheal Intubation Clinical Trial

— ExPress  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04381949
• Other study ID #: 2019/0351/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: May 2020
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 208
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Digestive Surgery With Orotracheal Intubation

Intervention

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"

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation rate	defined by a SpO2 < 92%	within one hour of tracheal extubation