COVID - 19PRODUR-CARDSNCT06765759
Prone Duration in COVID-19 ARDS
An observational study of COVID - 19 and Acute Respiratory Distress Syndrome (ARDS), run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID - 19, Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of Covid-19 ARDS patients hospitalized in the tertiary intensive care unit of a university hospital.
Who may be able to join
- >18 years old
- hospitalized for more than 48 hours
- patients diagnosed with COVID-19
- intubated patients
- underwent prone positioning for longer than 16 hours starting from the first session
Who cannot join
- Pregnant females
- Patients under the age of 18
- Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
Istanbul, 34153
About this study
Official title: Impact of Prone Position Duration and Sex Differences on Ventilation and Oxygenation in COVID-19 ARDS Patients: a Retrospective Cohort Study.
The aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is:
Does the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.
- Keywords
- COVID - 19, Acute Respiratory Distress Syndrome, Prone Position, Sex
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Short Prone | The group of patients who remained in prone position for 16-24 hours | |
| Long Prone | The group of patients who remained in prone position for 24-36 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of PaO2/FiO2 ratio during short and long prone periods
Partial arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) ratio changes before, during and after pronation at each group will be calculated.
Measured: At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.
Secondary outcomes (2)
Measurement of PaCO2 during short and long prone periods
Partial arterial carbon dioxide pressure (PaCO2) changes before, during and after pronation at each group will be measured.
Measured: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
Measurement of PEEP during short and long prone periods
Positive end-expiratory pressure (PEEP) changes before, during and after pronation at each group will be measured.
Measured: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID - 19Studies 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
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguzhan Kayhan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765759
- Sponsor's protocol ID
- 2023/789
- Acronym
- PRODUR-CARDS
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Approval was not obtained from the institute's ethics committee for sharing patient data with an international registry.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prone Position Duration and Sex Differences on Ventilation and Oxygenation in COVID-19 ARDS Patients: a Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06765759
- Acronym / sponsor ID
- PRODUR-CARDS / 2023/789
- Keywords
- COVID - 19, Acute Respiratory Distress Syndrome, Prone Position, Sex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 9 Jan 2025 (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 aim of this observational study is to learn the effects of prone position duration on patient outcomes in patients with severe acute respiratory distress syndrome (ARDS) due to Coronavirus Disease - 2019 (COVID-19). The main question it aims to answer is:
Does the length of prone position duration affect gas exchange in patients with severe ARDS and is there a difference between genders in this regard? The differences in gas exchange between those who have been in prone position for 16-24 hours and those who have been in prone position for 24-36 hours as part of severe ARDS treatment will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Prone | – | –The group of patients who remained in prone position for 16-24 hours |
| Long Prone | – | –The group of patients who remained in prone position for 24-36 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of Covid-19 ARDS patients hospitalized in the tertiary intensive care unit of a university hospital.
Key inclusion criteria (5 listed)
- >18 years old
- hospitalized for more than 48 hours
- patients diagnosed with COVID-19
- intubated patients
- underwent prone positioning for longer than 16 hours starting from the first session
Key exclusion criteria (3 listed)
- Pregnant females
- Patients under the age of 18
- Those who did not reach 16 hours duration of prone position for various reasons (unintentional extubation, ventilation problems, hemodynamic instability, cardiac arrest-prearrest)
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
Calculation of PaO2/FiO2 ratio during short and long prone periods
Time frame: At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.
Partial arterial oxygen pressure/Fraction of inspired oxygen (PaO2/FiO2) ratio changes before, during and after pronation at each group will be calculated.
2 secondary outcomes
Measurement of PaCO2 during short and long prone periods
Time frame: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
Measurement of PEEP during short and long prone periods
Time frame: At each prone session, measurement will be started one hour before the pronation and finished one hour after returning supine.
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 9 Jan 2025.
- Individual participant dataSharing planned: No. Approval was not obtained from the institute's ethics committee for sharing patient data with an international registry.
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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 COVID - 19 and Acute Respiratory Distress Syndrome (ARDS), run by Istanbul University - Cerrahpasa 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 5 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 9 Jan 2025. 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?
Calculation of PaO2/FiO2 ratio during short and long prone periods (time frame: At each prone session, calculation will be started one hour before the pronation and finished one hour after returning supine.). 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 9 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.