Acute Hypoxemic Respiratory FailureIntub_proneNCT05060926
Intubation Prediction in COVID-19 Patients Treated With Awake Prone Positioning
An observational study of Acute Hypoxemic Respiratory Failure and SARS-CoV-2 Virus, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, SARS-CoV-2 Virus
- What is being tested?
- Awake prone positioning
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2021to 30 Apr 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
- No healthy volunteers
- Adult, Older adult
Study population: Sars-CoV-2 pneumonia patients with severe hypoxemia
Who may be able to join
- Sars-CoV-2 pneumonia
- ICU stay
- Severe hypoxemia but non intubated
Who cannot join
- Intubated before admission
- Denied consent for data analysis
- Do not intubate order at ICU admission
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospitals
Lausanne, Canton of Vaud, 1011
About this study
Official title: Intubation Prediction in Sars-CoV-2 Patients Treated With Awake Prone Positioning
Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.
- Being tested
- Awake prone positioning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake prone positioningProcedure or surgery
Awake prone position as long as possible according to the patients' tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Measured: Once between ICU admission and extubation
Secondary outcomes (4)
Alveolo-arterial gradient change
Measured: Within 6 hours before and 6 hours after each pronation
Blood gas analysis
Measured: Within 6 hours before and 6 hours after each pronation
Respiratory pattern
Measured: Within 6 hours before and 6 hours after each pronation
Mortality
Measured: Up to 28 days from ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start16 Sep 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piquilloud Imboden Lise, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060926
- Sponsor's protocol ID
- Intub_prone
- Acronym
- Intub_prone
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Prediction in Sars-CoV-2 Patients Treated With Awake Prone Positioning
- ClinicalTrials.gov ID
- NCT05060926
- Acronym / sponsor ID
- Intub_prone / Intub_prone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Sep 2021 (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.
Retrospective study in Sars-Cov 2 patients hospitalised in ICU. We aim to explore the effects of Awake prone positioning on oxygenation and intubation rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sars-CoV-2 pneumonia patients with severe hypoxemia
Key inclusion criteria (3 listed)
- Sars-CoV-2 pneumonia
- ICU stay
- Severe hypoxemia but non intubated
Key exclusion criteria (3 listed)
- Intubated before admission
- Denied consent for data analysis
- Do not intubate order at ICU admission
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 |
|---|---|---|
| Awake prone positioningAwake prone position as long as possible according to the patients' tolerance | Procedure or surgery | – |
Primary outcome
Intubation rate
Time frame: Once between ICU admission and extubation
4 secondary outcomes
Alveolo-arterial gradient change
Time frame: Within 6 hours before and 6 hours after each pronation
Blood gas analysis
Time frame: Within 6 hours before and 6 hours after each pronation
Respiratory pattern
Time frame: Within 6 hours before and 6 hours after each pronation
Mortality
Time frame: Up to 28 days from ICU admission
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 3 Jun 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Acute Hypoxemic Respiratory Failure and SARS-CoV-2 Virus, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 3 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 3 Jun 2022. 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 Switzerland. 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?
Intubation rate (time frame: Once between ICU admission and 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 3 Jun 2022.