Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients With ARDS

• Sponsor: Bicetre Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05474196
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 14.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association Between Driving Transpulmonary Pressure and Extravascular Lung Water in Patients With ARDS
• Actual Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Outcome Measures

Primary Outcome Measures

1. Association between the transpulmonary driving pressure and the extravascular lung water (EVLW) [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.

Secondary Outcome Measures

1. Association between the transpulmonary driving pressure and the pulmonary vascular permeability index (PVPI) [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 PVPI values. We will calculate the correlation coefficient linking these two variables to assess if their association.

2. Correlation between the transpulmonary driving pressure at admission and the ICU-mortality [From inclusion up to hospital discharge (maximum day 60)]

   Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).

3. Correlation between the extravascular lung water at admission and the ICU-mortality [From inclusion up to hospital discharge (maximum day 60)]

   Multivariable analysis of factors associated with ICU mortality, including initial severity, comorbidities, respiratory mechanics covariates, EVLW and pulmonary vascular permeability index (PVPI).

4. Influence of position on plateau pressure [From inclusion up to hospital discharge (maximum day 60)]

   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.

5. Influence of position on plateau pressure on esophageal pressure [From inclusion up to hospital discharge (maximum day 60)]

   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.

6. Influence of position on plateau pressure on transpulmonary pressure [From inclusion up to hospital discharge (maximum day 60)]

   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.

7. Influence of position on plateau pressure on intra-abdominal pressure [From inclusion up to hospital discharge (maximum day 60)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Acute respiratory distress syndrome (ARDS)

• Monitoring with a transpulmonary thermodilution device

• Esophageal pressure monitoring

Exclusion Criteria:

• Legal protection measures

• Pregnancy

• Contra-indications of esophageal catheter : esophageal varicose, severe coagulopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Intensive Care Unit, Bicêtre Hospital	Le Kremlin-Bicêtre		France

Sponsors and Collaborators

• Bicetre Hospital

Investigators

• Principal Investigator: Tài Pham, MD, PhD, Hôpital Bicêtre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tai PHAM, Principal Investigator, Bicetre Hospital
• ClinicalTrials.gov Identifier: NCT05474196
• Other Study ID Numbers: 2022-A01289-34
• First Posted: Jul 26, 2022
• Last Update Posted: Jul 26, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Jul 26, 2022