COVID-19 Acute Respiratory Distress SyndromeSyDRAC-DVNCT05360862
Prone Positioning and R/I Ratio in COVID-19 Patients With ARDS (SyDRAC-DV)
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Prone positioning session
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2022to 29 Sep 2023
- 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: Eligible patients are COVID-19 patients with moderate to severe ARDS under mechanical ventilation in whom prone positioning is indicated.
Who may be able to join
- Invasive mechanical ventilation
- Patients with acute respiratory distress syndrome according to the Berlin definition
- Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples.
- Indication to a prone positioning session by the attending physician
Who cannot join
- Age <18 years and pregnant women
- Patients under legal protection
- Acute core pulmonale
- Pneumothorax and/or chest drainage
- Hemodynamic failure
- Increase in norepinephrine dosage >30% within the last 6 hours
- Norepinephrine dosage > 0.5 mg/kg/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome
The purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.
Read the detailed description
High positive end-expiratory pressure (PEEP) level and prone positioning (PP) are recommended in patients with moderate to severe acute respiratory distress syndrome (ARDS) in order to recruit lung and thus to improve oxygenation. Thus, high PEEP level and prone positioning will be more effective in patients with high potential for lung recruitment. Recently, the Recruitment-to-Inflation Ratio (R/I ratio) has been described and validated in patients with ARDS to estimate the potential for lung recruitment. In this regard, the R/I ration may be of interest to titrate PEEP level in patients with ARDS. This would be of particular interest in COVID-19 patients with ARDS, since different ARDS phenotypes with heterogeneous potential of lung recruitment have been described in these patients. However, the effects of prone positioning on R/I ratio have been scarcely described so far. Thus, the main goal of this study is to investigate the effects of prone positioning on the R/I ratio in COVID-19 patients with ARDS. The second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the R/I ratio.
- Being tested
- Prone positioning session
- Keywords
- ARDS, COVID-19, Prone positioning, Lung recruitement
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioning sessionProcedure or surgery
To perform respiratory measurements before, during and after a prone positioning session.
| Study group | Role | What they receive |
|---|---|---|
| Prone positioning session | Not described Receives: Procedure: Prone positioning session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prone positioning-induced decrease in R/I ratio.
The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session.
Measured: 16-hour prone positioning session and 4-hour period after supine repositioning
Secondary outcomes (2)
Proportion of patients "responders" to prone positioning session
The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session.
Measured: 16-hour prone positioning session and 4-hour period after supine repositioning
Clinical and respiratory predictors of prone positioning response in terms of oxygenation
TROC curves of clinical and biological variables for prediction of response to prone positioning
Measured: 16-hour prone positioning session and 4-hour period after supine repositioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start3 Nov 2022
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360862
- Sponsor's protocol ID
- 22-PP-02
- Acronym
- SyDRAC-DV
- Status last verified
- Feb 2024
- First submitted
- 3 May 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing data plan is sheduled.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prone Positioning-induced on the Recruitment-to-inflation Ratio in COVID-19 Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05360862
- Acronym / sponsor ID
- SyDRAC-DV / 22-PP-02
- Keywords
- ARDS, COVID-19, Prone positioning, Lung recruitement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 4 May 2022 (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 purpose of this study is to determine the efects of prone positioning on the recruitment- to-inflation ratio in COVID-19 patients with acute respiratory distress syndrome.
Detailed description
High positive end-expiratory pressure (PEEP) level and prone positioning (PP) are recommended in patients with moderate to severe acute respiratory distress syndrome (ARDS) in order to recruit lung and thus to improve oxygenation. Thus, high PEEP level and prone positioning will be more effective in patients with high potential for lung recruitment. Recently, the Recruitment-to-Inflation Ratio (R/I ratio) has been described and validated in patients with ARDS to estimate the potential for lung recruitment. In this regard, the R/I ration may be of interest to titrate PEEP level in patients with ARDS. This would be of particular interest in COVID-19 patients with ARDS, since different ARDS phenotypes with heterogeneous potential of lung recruitment have been described in these patients. However, the effects of prone positioning on R/I ratio have been scarcely described so far. Thus, the main goal of this study is to investigate the effects of prone positioning on the R/I ratio in COVID-19 patients with ARDS. The second goal of this study is to determine the effects of prone positioning on oxygenation and respiratory mechanics according to the R/I ratio.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone positioning session | – | Procedure: Prone positioning session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients are COVID-19 patients with moderate to severe ARDS under mechanical ventilation in whom prone positioning is indicated.
Key inclusion criteria (4 listed)
- Invasive mechanical ventilation
- Patients with acute respiratory distress syndrome according to the Berlin definition
- Positive COVID-19 real-time reverse transcriptase-polymerase chain reaction assay in nasal swabs or pulmonary samples.
- Indication to a prone positioning session by the attending physician
Key exclusion criteria (7 listed)
- Age <18 years and pregnant women
- Patients under legal protection
- Acute core pulmonale
- Pneumothorax and/or chest drainage
- Hemodynamic failure
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 positioning sessionTo perform respiratory measurements before, during and after a prone positioning session. | Procedure or surgery | Prone positioning session |
Primary outcome
Prone positioning-induced decrease in R/I ratio.
Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning
The R/I ratio will be calculated before (within 30 minutes before), during (2h, 8h and 16h) and after (2h and 4h after) a prone positioning session.
2 secondary outcomes
Proportion of patients "responders" to prone positioning session
Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning
Clinical and respiratory predictors of prone positioning response in terms of oxygenation
Time frame: 16-hour prone positioning session and 4-hour period after supine repositioning
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 8 Feb 2024.
- Individual participant dataSharing planned: No. No sharing data plan is sheduled.
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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 Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 4 inclusion and 7 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 8 Feb 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 France. 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?
Prone positioning-induced decrease in R/I ratio. (time frame: 16-hour prone positioning session and 4-hour period after supine repositioning). 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 8 Feb 2024.