SARS-CoV 2 PneumoniaNCT06517745
Effect of Prone Positionning in Non Intubated Patients
An observational study of SARS-CoV 2 Pneumonia and Acute Respiratory Distress Syndrome, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial summary
Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2 Pneumonia, Acute Respiratory Distress Syndrome, Prone Positioning
- What is being tested?
- Prone positioning
- Type of treatment
- Surgery or procedure
- How many people
- 114 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2021to 30 Oct 2021
- 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: All adult (> 18 years) patients admitted in the ICU: * with acute respiratory failure due to COVID-19 pulmonary infection * non intubated * regardeless of the exygenation method: HFONC, face mask, non invasive ventilation
Who may be able to join
- All adult (> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection
Who cannot join
- patients: hemodynamic instability and high doses of vasopressors
- patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
- patients with pulmonay embolism
- patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prone Positionning in Non Intubated ICU Patients With SARS-COV2
Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2
Read the detailed description
Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.
- Being tested
- Prone positioning
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningProcedure or surgery
Prone positioning sessions: at least one session per day proning duration: 2 hours at least per session
| Study group | Role | What they receive |
|---|---|---|
| Prone position group | Prone positioning sessions: at least 1 session per day session duration: at least 2 hours Receives: Procedure: Prone positioning | |
| Control group | no prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation
invasive mechanical ventilation requirement
Measured: at day 7
Intubation
invasive mechanical ventilation requirement
Measured: at day 14
Secondary outcomes (1)
ICU mortality
observed mortality rate in the ICU
Measured: at Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV 2 PneumoniaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517745
- Sponsor's protocol ID
- COVID PP
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Positionning in Non Intubated ICU Patients With SARS-COV2
- ClinicalTrials.gov ID
- NCT06517745
- Acronym / sponsor ID
- COVID PP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 24 Jul 2024 (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 single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2
Detailed description
Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone position group | – | Procedure: Prone positioningProne positioning sessions: at least 1 session per day session duration: at least 2 hours |
| Control group | – | –no prone positioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (> 18 years) patients admitted in the ICU: * with acute respiratory failure due to COVID-19 pulmonary infection * non intubated * regardeless of the exygenation method: HFONC, face mask, non invasive ventilation
Key inclusion criteria (1 listed)
- All adult (> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection
Key exclusion criteria (4 listed)
- patients: hemodynamic instability and high doses of vasopressors
- patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
- patients with pulmonay embolism
- patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery
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 |
|---|---|---|
| Prone positioningProne positioning sessions: at least one session per day proning duration: 2 hours at least per session | Procedure or surgery | Prone position group |
Primary outcome
Intubation
Time frame: at day 7
invasive mechanical ventilation requirement
Intubation
Time frame: at day 14
invasive mechanical ventilation requirement
1 secondary outcome
ICU mortality
Time frame: at Day 14
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 24 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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 SARS-CoV 2 Pneumonia and Acute Respiratory Distress Syndrome, run by Mongi Slim Hospital at 1 site in Tunisia.
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 1 inclusion and 4 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 24 Jul 2024. 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 Tunisia. 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 (time frame: at day 7). The study lists 2 primary outcomes in all. 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 24 Jul 2024.