Survival, ProsthesisNCT05866289
Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure
An observational study of Survival, Prosthesis and Oxygen Deficiency, run by Mohammed VI University Hospital at 1 site in Morocco.
Trial summary
The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Survival, Prosthesis, Oxygen Deficiency
- What is being tested?
- Prone position
- How many people
- 1,069 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Mar 2020to 30 Dec 2021
- How long will I take part?
- 22 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Each awake prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day. Epidemiological, clinical, paraclinical, therapeutic and evolutionary data were collected using a data processing form including the different variables collected in the patients' medical records. These data were then computerized and analyzed using IBM SPSS version 21 software. Qualitative variables were described as numbers and/or percentages, and quantitative variables as mean ± standard deviation, or as median with interquartile range for variables not having a normal distribution.
Who may be able to join
- all patients (1069 patients) with ARDS due to SARS-cov2, confirmed by nasopharyngeal swab, who were hospitalized in the COVID-19 ICU from March 1, 2020 to December 31, 2021
Who cannot join
- Patients with negative CRP
- Younger than 18 years of age
- Patients who died or intubated on the day of admission
- Patients presented a contraindication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure: Retrospective Cohort Study
The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Read the detailed description
The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as limited ICU capacity is strained by a new high-mortality disease and large numbers of patients requiring prolonged periods of hospitalization, as well as respiratory support equipment such as ventilators and intensive care unit (ICU) beds.
If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV vigil) remains a subject of debate and research.
This is a retrospective, monocentric, descriptive and analytical cohort conducted over a period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute respiratory failure caused by COVID-19.
- Conditions
- Survival, Prosthesis, Oxygen Deficiency
- Being tested
- Prone position
- Keywords
- acute respiratory distress syndrome, COVID-19, conscious, prone position, survival rate
- Medical subject headings
- Prosthesis Failure, Hypoxia, Respiratory Distress Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Each prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| Includes 681 patients who were placed in prone position | Not described Receives: Other: Prone position | |
| Includes 388 patients who were placed in supine position | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Measured: 22 months
Secondary outcomes (1)
length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Mar 2020
- Primary completion28 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Survival, ProsthesisStudies 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
- Other
- Enrolment
- 1,069 participants (actual)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- Mohammed VI University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Oujidi, Mohammed VI University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866289
- Sponsor's protocol ID
- unit critical care
- Status last verified
- May 2023
- First submitted
- 27 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Winearls S, Swingwood EL, Hardaker CL, Smith AM, Easton FM, Millington KJ, Hall RS, Smith A, Curtis KJ. Early conscious prone positioning in patients with COVID-19 receiving continuous positive airway pressure: a retrospective analysis. BMJ Open Respir Res. 2020 Sep;7(1):e000711. doi: 10.1136/bmjresp-2020-000711.
PubMed 32895247Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.
PubMed 32455107Despres C, Brunin Y, Berthier F, Pili-Floury S, Besch G. Prone positioning combined with high-flow nasal or conventional oxygen therapy in severe Covid-19 patients. Crit Care. 2020 May 26;24(1):256. doi: 10.1186/s13054-020-03001-6. No abstract available.
PubMed 32456663Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
PubMed 32000806Retucci M, Aliberti S, Ceruti C, Santambrogio M, Tammaro S, Cuccarini F, Carai C, Grasselli G, Oneta AM, Saderi L, Sotgiu G, Privitera E, Blasi F. Prone and Lateral Positioning in Spontaneously Breathing Patients With COVID-19 Pneumonia Undergoing Noninvasive Helmet CPAP Treatment. Chest. 2020 Dec;158(6):2431-2435. doi: 10.1016/j.chest.2020.07.006. Epub 2020 Jul 15. No abstract available.
PubMed 32679237Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.
PubMed 32569585
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Prone Positioning for COVID-19 Acute Hypoxaemic Respiratory Failure: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05866289
- Acronym / sponsor ID
- unit critical care
- Conditions
- Survival, Prosthesis, Oxygen Deficiency
- Keywords
- acute respiratory distress syndrome, COVID-19, conscious, prone position, survival rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,069 participants (actual)
- Lead sponsor
- Mohammed VI University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 May 2023 (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.
The objective of our study is to evaluate the effectiveness of prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Detailed description
The COVID-19 pandemic has challenged the management of hypoxemic respiratory failure as limited ICU capacity is strained by a new high-mortality disease and large numbers of patients requiring prolonged periods of hospitalization, as well as respiratory support equipment such as ventilators and intensive care unit (ICU) beds.
If early and prolonged prone positioning (DV) reduces mortality in invasively ventilated patients with acute respiratory distress syndrome (ARDS), its role in conscious patients (DV vigil) remains a subject of debate and research.
This is a retrospective, monocentric, descriptive and analytical cohort conducted over a period of 22 months from March 2020 to December 2021 and involving 1069 patients hospitalized in the intensive care unit of the CHU Mohammed VI of Oujda for the management of acute respiratory failure caused by COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 22 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Includes 681 patients who were placed in prone position | – | Other: Prone position |
| Includes 388 patients who were placed in supine position | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Each awake prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day. Epidemiological, clinical, paraclinical, therapeutic and evolutionary data were collected using a data processing form including the different variables collected in the patients' medical records. These data were then computerized and analyzed using IBM SPSS version 21 software. Qualitative variables were described as numbers and/or percentages, and quantitative variables as mean ± standard deviation, or as median with interquartile range for variables not having a normal distribution.
Key inclusion criteria (1 listed)
- all patients (1069 patients) with ARDS due to SARS-cov2, confirmed by nasopharyngeal swab, who were hospitalized in the COVID-19 ICU from March 1, 2020 to December 31, 2021
Key exclusion criteria (4 listed)
- Patients with negative CRP
- Younger than 18 years of age
- Patients who died or intubated on the day of admission
- Patients presented a contraindication
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 positionEach prone position session had a minimum duration of one hour and a maximum duration of 12 hours for a minimum of 3 hours per day. | Other | Includes 681 patients who were placed in prone position |
Primary outcome
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
Time frame: 22 months
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure.
1 secondary outcome
length of stay in intensive care unit, length of time from hospitalization to death, length of time from hospitalization to intubation.
Time frame: 22 months
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 19 May 2023.
- Background: PubMed 32895247Winearls S, Swingwood EL, Hardaker CL, Smith AM, Easton FM, Millington KJ, Hall RS, Smith A, Curtis KJ. Early conscious prone positioning in patients with COVID-19 receiving continuous positive airway pressure: a retrospective analysis. BMJ Open Respir Res. 2020 Sep;7(1):e000711. doi: 10.1136/bmjresp-2020-000711.
- Background: PubMed 32455107Sztajnbok J, Maselli-Schoueri JH, Cunha de Resende Brasil LM, Farias de Sousa L, Cordeiro CM, Sansao Borges LM, Malaque CMSA. Prone positioning to improve oxygenation and relieve respiratory symptoms in awake, spontaneously breathing non-intubated patients with COVID-19 pneumonia. Respir Med Case Rep. 2020;30:101096. doi: 10.1016/j.rmcr.2020.101096. Epub 2020 May 19.
- Background: PubMed 32456663Despres C, Brunin Y, Berthier F, Pili-Floury S, Besch G. Prone positioning combined with high-flow nasal or conventional oxygen therapy in severe Covid-19 patients. Crit Care. 2020 May 26;24(1):256. doi: 10.1186/s13054-020-03001-6. No abstract available.
- Background: PubMed 32000806Ding L, Wang L, Ma W, He H. Efficacy and safety of early prone positioning combined with HFNC or NIV in moderate to severe ARDS: a multi-center prospective cohort study. Crit Care. 2020 Jan 30;24(1):28. doi: 10.1186/s13054-020-2738-5.
- Background: PubMed 32679237Retucci M, Aliberti S, Ceruti C, Santambrogio M, Tammaro S, Cuccarini F, Carai C, Grasselli G, Oneta AM, Saderi L, Sotgiu G, Privitera E, Blasi F. Prone and Lateral Positioning in Spontaneously Breathing Patients With COVID-19 Pneumonia Undergoing Noninvasive Helmet CPAP Treatment. Chest. 2020 Dec;158(6):2431-2435. doi: 10.1016/j.chest.2020.07.006. Epub 2020 Jul 15. No abstract available.
- Background: PubMed 32569585Coppo A, Bellani G, Winterton D, Di Pierro M, Soria A, Faverio P, Cairo M, Mori S, Messinesi G, Contro E, Bonfanti P, Benini A, Valsecchi MG, Antolini L, Foti G. Feasibility and physiological effects of prone positioning in non-intubated patients with acute respiratory failure due to COVID-19 (PRON-COVID): a prospective cohort study. Lancet Respir Med. 2020 Aug;8(8):765-774. doi: 10.1016/S2213-2600(20)30268-X. Epub 2020 Jun 19.
- 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 Survival, Prosthesis and Oxygen Deficiency, run by Mohammed VI University Hospital at 1 site in Morocco.
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 19 May 2023. 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 Morocco. 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?
Evaluate the effectiveness of awake prone position in preventing intubation or death in spontaneously ventilated patients with COVID-19 with acute respiratory failure. (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866289, which also lists 6 linked publications.
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 19 May 2023.