Acute Respiratory Distress SyndromeDEBASNCT05922969
Safety of Low PEEP Maneuvers During ARDS Management
An observational study of Acute Respiratory Distress Syndrome and Positive End Expiratory Pressure, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Positive End Expiratory Pressure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2022to Nov 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: PEEP in patients with moderate or severe ARDS
Who may be able to join
- age : > 18 yo
- inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Yoann Zerbib, MD, 03 22 08 77 23, zerbib.yoann@chu-amiens.fr
Yoann Zerbib, 03 22 08 77 23, zerbib.yoann@chu-amiens.fr
About this study
Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.
The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS
- Keywords
- Acute Respiratory distress syndrome, Positive end expiratory pressure
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of oxygen desaturation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start28 May 2022
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier VALENCIENNES
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922969
- Sponsor's protocol ID
- PI2021_843_0165
- Acronym
- DEBAS
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Low PEEP Maneuvers During ARDS Management
- ClinicalTrials.gov ID
- NCT05922969
- Acronym / sponsor ID
- DEBAS / PI2021_843_0165
- Keywords
- Acute Respiratory distress syndrome, Positive end expiratory pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier VALENCIENNES
- Study start
- 28 May 2022 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 28 Jun 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.
Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.
The aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PEEP in patients with moderate or severe ARDS
Key inclusion criteria (2 listed)
- age : > 18 yo
- inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers
Key exclusion criteria (1 listed)
- refusal to participate
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
prevalence of oxygen desaturation
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 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.
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 Acute Respiratory Distress Syndrome and Positive End Expiratory Pressure, run by Centre Hospitalier Universitaire, Amiens 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 2 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: status not confirmed, as of the sponsor's last update on 10 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoann Zerbib, MD (03 22 08 77 23, Zerbib.yoann@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of oxygen desaturation (time frame: 24 months). 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 10 Jul 2024.