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OpenTrials
Completed

NCT Number: NCT04381949

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

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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"

Primary outcomes

  1. Desaturation rate

    Time frame: within one hour of tracheal extubation

    defined by a SpO2 < 92%

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: ExPress

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 11, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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