Weaning Mechanical VentilationWeaning-POPNCT07786519
Airway Occlusion Pressure Derived Parameters During Spotaneous Breathing Trial for Predicting Extubation Failure
An observational study of Weaning Mechanical Ventilation, run by Rennes University Hospital at 4 sites in France.
Trial summary
Weaning from invasive mechanical ventilation (IMV) is a critical stage of the intensive care unit (ICU) stay. Premature IMV discontinuation may expose patients to substantial cardiopulmonary stress, whereas prolonged weaning increases exposure to complications associated with IMV, including ventilator-associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Mechanical Ventilation
- How many people
- 225 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Apr 2024to 3 Sep 2025
- How long will I take part?
- 40 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted in four critical care units in the Brittany region of France over a 12-month period, using the ventilators available at each center without specific selection, to best reflect usual clinical practices: a tertiary academic surgical ICU at Rennes University Hospital (30 beds) and three general ICUs at Saint-Brieuc Hospital (21 beds), Saint-Malo Hospital (15 beds), and Vannes Hospital (20 beds).
Who may be able to join
- Adult patients meeting all the weaning criteria set out in the consensus of the International Conference on Weaning:
- Duration of mechanical ventilation prior to the first weaning trial > 24 hours
- Respiratory rate ≤ 35 breaths/min,
- Adequate oxygenation defined as SpO₂ ≥ 90% with FiO₂ ≤ 0.4 or PaO₂/FiO₂ ≥ 150 mm Hg with PEEP ≤ 8 cmH₂O,
- Adequate cough reflex,
- A conscious patient who is responsive to commands and has a RASS (Richmond Agitation Sedation Scale) score between +1 and -2
- Haemodynamically stable without vasopressors or on a minimal dose (noradrenaline <0.1 µg/kg/min)
- Patient informed about the study and expressing no objection to participating
Who cannot join
- Patients with neurological injury and a Glasgow Motor Score of ≤ M5
- Decision not to reintubate in the event of extubation failure
- Adults subject to legal protection (judicial protection, curatorship, guardianship), and persons deprived of their liberty
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU de Rennes
Rennes
Centre hospitalier de Saint Brieuc
Saint-Brieuc
Centre hospitalier de Saint Malo
St-Malo
Centre Hospitalier Bretagne Atlantique
Vannes
About this study
Official title: The Predictive Value of Airway Occlusion Pressure Derived Parameters During Spontaneous Breathing Trial on Successful Weaning From Mechanical Ventilation
Weaning from invasive mechanical ventilation (IMV) is a critical stage of the intensive care unit (ICU) stay. Premature IMV discontinuation may expose patients to substantial cardiopulmonary stress, whereas prolonged weaning increases exposure to complications associated with IMV, including ventilator-associated pneumonia (VAP), diaphragmatic muscle atrophy, and barotrauma.
Extubation failure, defined as the need for reintubation within 48-72 h after extubation, occurs in approximately 10-15% of patients reaching 20% in high-risk patients including factors of age >65 years, chronic cardiac or respiratory disease, IMV duration >7 days. Extubation failure is associated with substantial morbidity and mortality, with reported hospital mortality rates up to 25-50%, as well as prolonged ICU length of stay and increased healthcare costs.
Read more
Modern ventilators provide simple, non-invasive access to two complementary physiological indices: the airway occlusion pressure at 100 ms (P0.1), a surrogate of central respiratory drive, and the change in inspiratory pressure during an occlusion maneuver (ΔPocc), a marker of the overall inspiratory effort.
This study assesses the predictive value of P0.1 and ΔPocc measured before and during an SBT for predicting reintubation within 3 days after extubation.
- Conditions
- Weaning Mechanical Ventilation
- Keywords
- ICU, MEchanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with mechanical ventilation elligible for weaning | Conducting a systematic measurement of respiratory effort markers during a weaning trial with inspiratory support during the stay in ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reintubation rate within 3 days after extubation
Number of patients requiring reintubation within 3 days following extubation
Measured: 3 days following extubation
Secondary outcomes (5)
Reintubation rate within 2 days after extubation
Number of patients requiring reintubation within 2 days following extubation
Measured: 2 days following extubation
Reintubation rate within 7 days after extubation
Number of patients requiring reintubation within 7 days following extubation
Measured: 7 days following extubation
ICU mortality
Number of patients who died during the stay in ICU
Measured: From ICU admission to ICU discharge or death, assessed up to 60 days
ICU length of stay
the length of time between admission to and discharge from the intensive care unit
Measured: Between admission to and discharge from the ICU, assessed up to 60 days
Hospital length of stay
The length of time between admission to the ICU and discharge from the hospital
Measured: From ICU admission to hospital discharge, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start17 Apr 2024
- Primary completion17 Apr 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weaning Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
- Target duration
- 40 Days
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786519
- Sponsor's protocol ID
- 35RC23_9774_04
- Acronym
- Weaning-POP
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial may be made available, following the initial publication of the results, to any researchers who submit a methodologically sound proposal. Proposals must be submitted to the study contact point. To gain access to the data, applicants will be required to sign a data access agreement; additional formalities may be required, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Airway Occlusion Pressure Derived Parameters During Spontaneous Breathing Trial on Successful Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT07786519
- Acronym / sponsor ID
- Weaning-POP / 35RC23_9774_04
- Conditions
- Weaning Mechanical Ventilation
- Keywords
- ICU, MEchanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 26 Aug 2026 (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.
Weaning from invasive mechanical ventilation (IMV) is a critical stage of the intensive care unit (ICU) stay. Premature IMV discontinuation may expose patients to substantial cardiopulmonary stress, whereas prolonged weaning increases exposure to complications associated with IMV, including ventilator-associated pneumonia (VAP), diaphragmatic muscle atrophy, and barotrauma.
Extubation failure, defined as the need for reintubation within 48-72 h after extubation, occurs in approximately 10-15% of patients reaching 20% in high-risk patients including factors of age >65 years, chronic cardiac or respiratory disease, IMV duration >7 days. Extubation failure is associated with substantial morbidity and mortality, with reported hospital mortality rates up to 25-50%, as well as prolonged ICU length of stay and increased healthcare costs.
Modern ventilators provide simple, non-invasive access to two complementary physiological indices: the airway occlusion pressure at 100 ms (P0.1), a surrogate of central respiratory drive, and the change in inspiratory pressure during an occlusion maneuver (ΔPocc), a marker of the overall inspiratory effort.
This study assesses the predictive value of P0.1 and ΔPocc measured before and during an SBT for predicting reintubation within 3 days after extubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 40 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with mechanical ventilation elligible for weaning | – | –Conducting a systematic measurement of respiratory effort markers during a weaning trial with inspiratory support during the stay in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in four critical care units in the Brittany region of France over a 12-month period, using the ventilators available at each center without specific selection, to best reflect usual clinical practices: a tertiary academic surgical ICU at Rennes University Hospital (30 beds) and three general ICUs at Saint-Brieuc Hospital (21 beds), Saint-Malo Hospital (15 beds), and Vannes Hospital (20 beds).
Key inclusion criteria (8 listed)
- Adult patients meeting all the weaning criteria set out in the consensus of the International Conference on Weaning:
- Duration of mechanical ventilation prior to the first weaning trial > 24 hours
- Respiratory rate ≤ 35 breaths/min,
- Adequate oxygenation defined as SpO₂ ≥ 90% with FiO₂ ≤ 0.4 or PaO₂/FiO₂ ≥ 150 mm Hg with PEEP ≤ 8 cmH₂O,
- Adequate cough reflex,
Key exclusion criteria (3 listed)
- Patients with neurological injury and a Glasgow Motor Score of ≤ M5
- Decision not to reintubate in the event of extubation failure
- Adults subject to legal protection (judicial protection, curatorship, guardianship), and persons deprived of their liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reintubation rate within 3 days after extubation
Time frame: 3 days following extubation
Number of patients requiring reintubation within 3 days following extubation
5 secondary outcomes
Reintubation rate within 2 days after extubation
Time frame: 2 days following extubation
Reintubation rate within 7 days after extubation
Time frame: 7 days following extubation
ICU mortality
Time frame: From ICU admission to ICU discharge or death, assessed up to 60 days
ICU length of stay
Time frame: Between admission to and discharge from the ICU, assessed up to 60 days
Hospital length of stay
Time frame: From ICU admission to hospital discharge, assessed up to 90 days
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial may be made available, following the initial publication of the results, to any researchers who submit a methodologically sound proposal. Proposals must be submitted to the study contact point. To gain access to the data, applicants will be required to sign a data access agreement; additional formalities may be required, as appropriate.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning Mechanical Ventilation, run by Rennes University Hospital at 4 sites 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 8 inclusion and 3 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Reintubation rate within 3 days after extubation (time frame: 3 days following 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 26 Aug 2026.