ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2NCT05115526
PEEP Setting in COVID19-related ARDS
An observational study of ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2
- What is being tested?
- PEEP setting
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 May 2021
- 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: Consecutive adult patients under mechanical ventilation following COVID19-ARDS
Who may be able to join
- COVID19-related ARDS under invasive mechanical ventilation
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.
The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.
Read the detailed description
COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.
- Being tested
- PEEP setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP settingOther
PEEP setting according to various methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of PEEP
different PEEP values obtained through using different methods
Measured: a single determination, within 24-48 hours after mechanical ventilation initiation
Secondary outcomes (1)
Respiratory mechanics
Respiratory mechanics (plateau pressure, driving pressure, compliance, mechanical power) following different PEEP settings
Measured: a single determination, within 24-48 hours after mechanical ventilation initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Mar 2021
- Primary completion15 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115526
- Sponsor's protocol ID
- 2021PI117
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 10 Nov 2021
- 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 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure.
- ClinicalTrials.gov ID
- NCT05115526
- Acronym / sponsor ID
- 2021PI117
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 10 Nov 2021 (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 best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.
Detailed description
COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients under mechanical ventilation following COVID19-ARDS
Key inclusion criteria (1 listed)
- COVID19-related ARDS under invasive mechanical ventilation
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| PEEP settingPEEP setting according to various methods | Other | – |
Primary outcome
Value of PEEP
Time frame: a single determination, within 24-48 hours after mechanical ventilation initiation
different PEEP values obtained through using different methods
1 secondary outcome
Respiratory mechanics
Time frame: a single determination, within 24-48 hours after mechanical ventilation initiation
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 10 Nov 2021.
- Individual participant dataSharing planned: No
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 ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2, run by Central Hospital, Nancy, France 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 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 10 Nov 2021. 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?
Value of PEEP (time frame: a single determination, within 24-48 hours after mechanical ventilation initiation). 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 Nov 2021.