Interest of Tracheal Extubation in Positive Pressure on P... | NCT04381949

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

NCT04381949

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Feb 17, 2026Actual

Enrollment

208Actual

Phase

Not Applicable

Conditions

Airway Management
Tracheal Extubation
Postoperative Respiratory Complications
Postoperative Hypoxemia
Atelectasis
General Anesthesia
Mechanical Ventilation

Interventions

positive pressure extubation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2022Actual

Primary Completion Date

Jan 19, 2026Actual

Completion Date

Jan 19, 2026Actual

First Submitted Date

May 6, 2020

First Submission Date that Met QC Criteria

May 6, 2020

First Posted Date

May 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2026

Last Update Posted Date

Feb 17, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Conditions Module

Conditions

Airway Management
Tracheal Extubation
Postoperative Respiratory Complications
Postoperative Hypoxemia
Atelectasis
General Anesthesia
Mechanical Ventilation

Keywords

Tracheal Extubation
Positive Pressure Extubation
Positive End-Expiratory Pressure (PEEP)
Airway Management
Postoperative Desaturation
Postoperative Hypoxemia
Atelectasis
Mechanical Ventilation
General Anesthesia
Respiratory Complications
Post-Anesthesia Care Unit (PACU)
Adult Surgery

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard extubation Arm	No Intervention
Positive pressure extubation arm	Experimental		Procedure: positive pressure extubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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"

Measure	Description	Time Frame
Desaturation rate	defined by a SpO2 < 92%	within one hour of tracheal extubation

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases