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

U

University Hospital, Rouen

Status

Unknown

Conditions

Patients Undergoing Digestive Surgery With Orotracheal Intubation

Treatments

Procedure: positive pressure extubation

Study type

Interventional

Funder types

Other

Identifiers

NCT04381949
2019/0351/HP

Details and patient eligibility

About

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

Enrollment

208 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

208 participants in 2 patient groups

Standard extubation Arm
No Intervention group
Positive pressure extubation arm
Experimental group
Treatment:
Procedure: positive pressure extubation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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