ExtubationEXTUBPOSNCT05295095
Does Positive Pressure Extubation Reduce Postoperative Desaturation?
A study testing positive pressure during extubation procedure in people with Extubation and Postoperative Complications, run by University Hospital, Lille at 1 site in France.
Trial summary
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extubation, Postoperative Complications, Lung Ultrasound Score
- What is being tested?
- positive pressure during extubation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2022to 19 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques on postoperative desaturations
Read the detailed description
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
- Being tested
- positive pressure during extubation procedure
- Keywords
- positive pressure extubation, Postoperative Complications, lung ultrasound score
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive pressure during extubation procedureProcedure or surgery
positive pressure during extubation procedure
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Classical extubation technique : ETT was removed with continuous endotracheal suction |
| VSPEP | Experimental | ETT was removed with APL valve set to 20cmH2O Receives: Procedure: positive pressure during extubation procedure |
| VSAIPEP | Experimental | ETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room Receives: Procedure: positive pressure during extubation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
desaturations during extubation
saturation <92%
Measured: 1 minute after extubation
Secondary outcomes (7)
desaturation postoperatory
saturation<92%
Measured: 5 and 30 minutes after extubation
hypoxemia post operatory
PaO2 <60mmHg
Measured: 1 and 30 minutes after extubation
atelectasis
Lung ultrasound score (LUS); min = 0, max = 32, higher scores mean is worse outcome
Measured: 30 minutes after extubation
awakening time
time in seconds
Measured: through extubation completion, an average 2 minutes
use of oxygen
days Numbers of oxygen therapy, kinesiotherapy, non invasive ventilation
Measured: day 7
post operative complications
Clavien Dindo Score; min = grade I, max = grade V; higher scores mean is worse outcome
Measured: day 7 and day 28
feasibility and acceptance of both techniques pressure positive extubation
questionnaire, min = 4, max =20, higher scores mean is worse outcome
Measured: 15 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start29 Jun 2022
- Primary completion8 Jan 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédric CIRENEI, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295095
- Sponsor's protocol ID
- 2021_0433
- Other IDs
- 2021-A03064-37
- Acronym
- EXTUBPOS
- Status last verified
- May 2026
- First submitted
- 21 Feb 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Positive Pressure Extubation in Reducing Postoperative Desaturation Episodes in Adults Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05295095
- Acronym / sponsor ID
- EXTUBPOS / 2021_0433
- Keywords
- positive pressure extubation, Postoperative Complications, lung ultrasound score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-center, prospective, controlled, parallel, randomized, single-blind study comparing the conventional extubation technique to two positive pressure extubation techniques
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Classical extubation technique : ETT was removed with continuous endotracheal suction |
| VSPEP | Experimental | Procedure: positive pressure during extubation procedureETT was removed with APL valve set to 20cmH2O |
| VSAIPEP | Experimental | Procedure: positive pressure during extubation procedureETT removed with ventilator parameters were set for PSV mode (inspiratory pressure of 10cmH2O and PEEP identical to that administered in the operating room |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positive pressure during extubation procedurepositive pressure during extubation procedure | Procedure or surgery | VSAIPEP, VSPEP |
Primary outcome
desaturations during extubation
Time frame: 1 minute after extubation
saturation <92%
7 secondary outcomes
desaturation postoperatory
Time frame: 5 and 30 minutes after extubation
hypoxemia post operatory
Time frame: 1 and 30 minutes after extubation
atelectasis
Time frame: 30 minutes after extubation
awakening time
Time frame: through extubation completion, an average 2 minutes
use of oxygen
Time frame: day 7
post operative complications
Time frame: day 7 and day 28
feasibility and acceptance of both techniques pressure positive extubation
Time frame: 15 minutes after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric CIRENEI, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive pressure during extubation procedure in people with Extubation and Postoperative Complications, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
desaturations during extubation (time frame: 1 minute after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.