Airway ManagementExPressNCT04381949
Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery
A study testing positive pressure extubation in people with Airway Management and Tracheal Extubation, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Airway Management, Tracheal Extubation, Postoperative Respiratory Complications
- What is being tested?
- positive pressure extubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2022to 26 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study
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
- Conditions
- Airway Management, Tracheal Extubation, Postoperative Respiratory Complications, Postoperative Hypoxemia, Atelectasis, General Anesthesia
- Being tested
- positive pressure extubation
- 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
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive pressure extubationProcedure or surgery
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"
| Study group | Role | What they receive |
|---|---|---|
| Standard extubation Arm | No intervention | Not described |
| Positive pressure extubation arm | Experimental | Not described Receives: Procedure: positive pressure extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desaturation rate
defined by a SpO2 < 92%
Measured: within one hour of tracheal extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start3 Aug 2022
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381949
- Sponsor's protocol ID
- 2019/0351/HP
- Acronym
- ExPress
- Status last verified
- Feb 2026
- First submitted
- 6 May 2020
- Last updated
- 6 Nov 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 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Tracheal Extubation in Positive Pressure on Postoperative Oxygenation in Adult Digestive Surgery: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04381949
- Acronym / sponsor ID
- ExPress / 2019/0351/HP
- Conditions
- Airway Management, Tracheal Extubation, Postoperative Respiratory Complications, Postoperative Hypoxemia, Atelectasis, General Anesthesia
- Keywords
- Tracheal Extubation, Positive Pressure Extubation, Positive End-Expiratory Pressure (PEEP), Airway Management, Postoperative Desaturation, Postoperative Hypoxemia, Atelectasis, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 11 May 2020 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard extubation Arm | No intervention | – |
| Positive pressure extubation arm | Experimental | Procedure: positive pressure extubation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
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 extubationTwo arms: the first with "classic" extubation with disconnection of the ventilator and the second with an extubation without disconnection of the respiratory "positive pressure" | Procedure or surgery | Positive pressure extubation arm |
Primary outcome
Desaturation rate
Time frame: within one hour of tracheal extubation
defined by a SpO2 < 92%
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 Nov 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.
The record lists no contact. Use the official record to reach the sponsor.
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 extubation in people with Airway Management and Tracheal Extubation, run by University Hospital, Rouen 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 4 inclusion and 18 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 Nov 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?
Desaturation rate (time frame: within one hour of tracheal 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 Nov 2026.