Acute Respiratory Distress SyndromeNCT05474196
Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS
An observational study of Acute Respiratory Distress Syndrome, run by Bicetre Hospital at 1 site in France.
Trial summary
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2022to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 intubated in the medical ICU of Bicêtre hospital (Academic hospital), Le Kremlin Bicêtre, France
Who may be able to join
- Acute respiratory distress syndrome (ARDS)
- Monitoring with a transpulmonary thermodilution device
- Esophageal pressure monitoring
Who cannot join
- Legal protection measures
- Pregnancy
- Contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Medical Intensive Care Unit, Bicêtre Hospital
Le Kremlin-Bicêtre
Tài Pham, MD, +33145217245, tai.pham@gmail.com
About this study
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).
One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.
So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)
On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and extra-vascular lung water values. We will calculate the correlation coefficient linking these two variables to assess if their association.
Measured: From inclusion up to hospital discharge (maximum day 60)
Secondary outcomes (7)
Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)
On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and PVPI values. We will calculate the correlation coefficient linking these two variables to assess if their association.
Measured: From inclusion up to hospital discharge (maximum day 60)
Correlation between the transpulmonary driving pressure at admission and the ICU-mortality
Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Measured: From inclusion up to hospital discharge (maximum day 60)
Correlation between the extravascular lung water at admission and the ICU-mortality
Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).
Measured: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure
Plateau pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Measured: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on esophageal pressure
Esophageal pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Measured: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on transpulmonary pressure
Transpulmonary pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Measured: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on intra-abdominal pressure
Intra-abdominal pressure will be measured at 0°, 30° and 45° position and we will compare the values to assess if the position impacts this pressure.
Measured: From inclusion up to hospital discharge (maximum day 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Feb 2022
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tai PHAM, Bicetre Hospital
- Investigators
- Tài Pham, MD, PhD, Principal investigator, Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474196
- Sponsor's protocol ID
- 2022-A01289-34
- Status last verified
- Feb 2025
- First submitted
- 19 Jul 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients with ARDS
- ClinicalTrials.gov ID
- NCT05474196
- Acronym / sponsor ID
- 2022-A01289-34
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 26 Jul 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.
Intubated patients with the acute respiratory distress syndrome (ARDS) are usually treated with protective ventilation limiting plateau pressure below 30 centimeter of water (cmH2O) and, if possible, a driving pressure under 15 cmH2O. However, these airway pressures might not reflect the actual pressure applied to the lung. Transpulmonary pressure is the difference between airway pressure and pleural pressure, the latter is estimated by the esophageal pressure, and so it better reflects the ventilatory induced lung injury (VILI).
One of the consequences of the VILI is a increase of pulmonary edema and it could be estimated by the extravascular lung water, obtained by trans-pulmonary thermodilution.
So it could exist a link between the driving trans-pulmonary pressure and the extravascular lung water.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients intubated in the medical ICU of Bicêtre hospital (Academic hospital), Le Kremlin Bicêtre, France
Key inclusion criteria (3 listed)
- Acute respiratory distress syndrome (ARDS)
- Monitoring with a transpulmonary thermodilution device
- Esophageal pressure monitoring
Key exclusion criteria (3 listed)
- Legal protection measures
- Pregnancy
- Contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy
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
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW)
Time frame: From inclusion up to hospital discharge (maximum day 60)
On the first day of patient's respiratory and hemodynamics monitoring, we will collect transpulmonary driving pressure and extra-vascular lung water values. We will calculate the correlation coefficient linking these two variables to assess if their association.
7 secondary outcomes
Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI)
Time frame: From inclusion up to hospital discharge (maximum day 60)
Correlation between the transpulmonary driving pressure at admission and the ICU-mortality
Time frame: From inclusion up to hospital discharge (maximum day 60)
Correlation between the extravascular lung water at admission and the ICU-mortality
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on esophageal pressure
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on transpulmonary pressure
Time frame: From inclusion up to hospital discharge (maximum day 60)
Influence of position on plateau pressure on intra-abdominal pressure
Time frame: From inclusion up to hospital discharge (maximum day 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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.
Tài Pham, MD, PhD principal investigator
Hôpital Bicêtre
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, run by Bicetre Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tài Pham, MD, PhD. (+33145217245, tai.pham@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the transpulmonary driving pressure and the extravascular lung water (EVLW) (time frame: From inclusion up to hospital discharge (maximum day 60)). 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 11 Feb 2025.