MoralityNCT06530095
We Compared the Covid-19 Acute Respiratory Distress Syndrome (ARDS) Patients Who Applied Prone Positioning for16-24 Hours vs 24-48 Hours
An observational study of Morality and Oxygenation Indices, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning. Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morality, Oxygenation Indices, Hypoxia
- What is being tested?
- prone positioning
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2022to 15 Feb 2024
- 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: Patients who have been admitted in ICU and diagnosed with Covid-19 ARDS.
Who may be able to join
- COVİD 19 ARDS patients patients who have been intubated for 48 hours and more
Who cannot join
- Pediatric patients Patients who extubated in less than 48 hours Patients with Lung and pleural malignancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi konuk Research and Training hospital
Istanbul, 34450
About this study
Official title: ''Impact of Early vs. Delayed Prone Positioning on Oxygenation and Mortality in COVID-19 ARDS Patients: A Retrospective Analysis''
The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.
Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.
- Conditions
- Morality, Oxygenation Indices, Hypoxia
- Being tested
- prone positioning
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prone positioningOther
prone positioning
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who have been in prone positioning for 16-24 hours Receives: Other: prone positioning | |
| Group B | Patients who have been in prone positioning for 24-48 hours Receives: Other: prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation Index (OSI)
OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2
Measured: 48 hours
Oxygenation Index
Oxygenation index is calculated as OI = MAP × Fio2 × 100 / Pao2, where MAP indicates mean airway pressure and Fio2 indicates fraction of inspired oxygen
Measured: 48 hours
Secondary outcomes (1)
ICU mortality
mortality rates during patients admission in the ICU
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start3 Oct 2022
- Primary completion3 Jan 2023
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoralityStudies 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
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530095
- Sponsor's protocol ID
- 2022/318
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''Impact of Early vs. Delayed Prone Positioning on Oxygenation and Mortality in COVID-19 ARDS Patients: A Retrospective Analysis''
- ClinicalTrials.gov ID
- NCT06530095
- Acronym / sponsor ID
- 2022/318
- Conditions
- Morality, Oxygenation Indices, Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 31 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.
The goal of this study is to understand if there is any improvement on oxygenation of patients diagnosed with Covid-19 ARDS patients when we extend the duration of prone positioning.
Second outcome of the study is to investigate mortality of patients when we extend the duration of prone positioning.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: prone positioningPatients who have been in prone positioning for 16-24 hours |
| Group B | – | Other: prone positioningPatients who have been in prone positioning for 24-48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have been admitted in ICU and diagnosed with Covid-19 ARDS.
Key inclusion criteria (1 listed)
- COVİD 19 ARDS patients patients who have been intubated for 48 hours and more
Key exclusion criteria (1 listed)
- Pediatric patients Patients who extubated in less than 48 hours Patients with Lung and pleural malignancies
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 | Other | Group A, Group B |
Primary outcome
Oxygen Saturation Index (OSI)
Time frame: 48 hours
OSI is calculated by dividing the product of mean airway pressure (MAP) and FiO2 with SpO2
Oxygenation Index
Time frame: 48 hours
Oxygenation index is calculated as OI = MAP × Fio2 × 100 / Pao2, where MAP indicates mean airway pressure and Fio2 indicates fraction of inspired oxygen
1 secondary outcome
ICU mortality
Time frame: 28 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 31 Jul 2024.
- 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 Morality and Oxygenation Indices, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 1 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 31 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 Turkey (Türkiye). 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?
Oxygen Saturation Index (OSI) (time frame: 48 hours). 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 31 Jul 2024.