Respiratory FailureNCT04654273
EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure
An observational study of Respiratory Failure, run by Poitiers University Hospital at 1 site in France.
Trial summary
Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2020to 31 Jan 2022
- 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
- Adult, Older adult
Study population: Patients hospitalized in surgical or neurosurgical intensive care units of CHU de Poitiers, under mechanical ventilation for more than 48 hours, meeting the criteria for severability.
Who may be able to join
- Age ≥ 18 years old,
- Hospitalized in surgical or neurosurgical intensive care units
- Patients under mechanical ventilation for more than 48 hours,
- Meeting the criteria for severability (spontaneous ventilation test),
- Free subject, without tutorship or curatorship or subordination,
- Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party,
- No objection given by the patient and / or relative after clear and fair information about the study.
Who cannot join
- Tracheostomized patients,
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection,
- Pregnant and / or lactating women.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU POitiers
Poitiers, 86000
Damien Marie, Dr
About this study
Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.
- Conditions
- Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of re-intubations after extubation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start30 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Poitiers 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
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654273
- Sponsor's protocol ID
- EX-PO
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2020
- Last updated
- 8 Jul 2021
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure
- ClinicalTrials.gov ID
- NCT04654273
- Acronym / sponsor ID
- EX-PO
- Conditions
- Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 4 Dec 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.
Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in surgical or neurosurgical intensive care units of CHU de Poitiers, under mechanical ventilation for more than 48 hours, meeting the criteria for severability.
Key inclusion criteria (7 listed)
- Age ≥ 18 years old,
- Hospitalized in surgical or neurosurgical intensive care units
- Patients under mechanical ventilation for more than 48 hours,
- Meeting the criteria for severability (spontaneous ventilation test),
- Free subject, without tutorship or curatorship or subordination,
Key exclusion criteria (3 listed)
- Tracheostomized patients,
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection,
- Pregnant and / or lactating women.
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
Number of re-intubations after extubation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure, run by Poitiers University Hospital 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 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien MARIE, Dr (05.49.44.15.65, damien.marie@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of re-intubations after extubation (time frame: 7 days). 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 8 Jul 2021.