Does Positive Pressure Extubation Reduce Postoperative Desaturation?

NCT ID: NCT05295095

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study realise on university hospital on Lille in France. Patients inclusion is prospective and randomised in three groups. First group : extubation is realised with aspiration in tracheal tube during removal tube Second group : extubation is realised without aspiration but with APL valve set to 20cmH20 Third group : extubation is realised without aspiration but with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Extubation Postoperative Complications Lung Ultrasound Score

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
patients under anaesthesia at randomization

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

control group

Classical extubation technique : ETT was removed with continuous endotracheal suction

Group Type NO_INTERVENTION

No interventions assigned to this group

VSPEP

ETT was removed with APL valve set to 20cmH2O

Group Type EXPERIMENTAL

positive pressure during extubation procedure

Intervention Type PROCEDURE

positive pressure during extubation procedure

VSAIPEP

ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room

Group Type EXPERIMENTAL

positive pressure during extubation procedure

Intervention Type PROCEDURE

positive pressure during extubation procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

positive pressure during extubation procedure

positive pressure during extubation procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Visceral or urological surgery
* Scheduled surgery
* Surgical or patient requirement: placement of an arterial catheter
* Supine position
* Post-surgical extubation scheduled in the operating room
* Minimum age of 18 years
* Informed and signed consent

Exclusion Criteria

* Severe obesity (BMI over 35kg/m2)
* pregnant woman
* Acute or chronic preoperative respiratory pathology.
* Sleep apnea syndrome
* Inability to receive informed information (does not speak, read or understand French)
* Patient under guardianship or curatorship
* Lack of social security coverage
* History of intubation or criteria for difficult intubation or ventilation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cédric CIRENEI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cédric CIRENEI, MD

Role: CONTACT

0320445962 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A03064-37

Identifier Type: OTHER

Identifier Source: secondary_id

2021_0433

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LIght Sedation Pressure Support
NCT03783468 WITHDRAWN NA