V/Q Matching Variations With PEEP in ARDS According to Compliance-based Phenotypes (France)

NCT05578742 | Recruiting DMC

• 1 other identifier: 2022-A00649-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to compare the effect of Positive End Expiratory Pressure (PEEP) on ventilation/perfusion mismatch in two phenotypes of patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS), characterized by their respiratory system elastance (Ers). Ventilation/perfusion mismatch will be assessed by Electrical Impedance Tomography (EIT).

Conditions

ARDS

Keywords

pulmonary perfusion; ventilation-perfusion mismatch; compliance; recruitability

Outcome Measures

Primary Outcomes (1)

• Difference in ventilation/perfusion mismatch between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  Ventilation/perfusion (V/Q) mismatch will be assessed by Electrical Impedance Tomography (EIT). Mismatch is expressed in %. Comparison between phenotype with higher and lower elastance will be performed.

  immediately after each intervention

Secondary Outcomes (10)

• Difference in respiratory mechanics between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  immediately after each intervention

• Difference in oxygenation between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  immediately after each intervention

• Difference in carbon clearance between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  immediately after each intervention

• Difference in dead space measured by capnometric volumetry between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  immediately after each intervention

• Difference in dead space measured by calorimetry between PEEP 5 and 15 cmH2O according to the two studied phenotypes

  immediately after each intervention

Study Arms (2)

Strategy A: PEEP 15 cmH2O → PEEP 5 cmH2O

EXPERIMENTAL

Procedure: PEEP decrease

Strategy B: PEEP 5 cmH2O → PEEP 15 cmH2O

ACTIVE COMPARATOR

Procedure: PEEP increase

Interventions

PEEP increase PROCEDURE

Positive End Expiratory Pressure (PEEP) will be increased from 5 to 15 cmH2O.

Strategy B: PEEP 5 cmH2O → PEEP 15 cmH2O

PEEP decrease PROCEDURE

Positive End Expiratory Pressure (PEEP) will be decreased from 15 to 5 cmH2O.

Strategy A: PEEP 15 cmH2O → PEEP 5 cmH2O

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• intubated patients with moderate and severe ARDS (Berlin definition, PaO2/FiO2 ≤200 mmHg at PEEP 5 cmH2O)
• undergoing deep sedation
• on controlled mechanical ventilation
• between 24 hours and 5 days after intubation.

You may not qualify if:

• age \<18 years old; pregnancy
• patient undergoing legal protection
• contra-indications to EIT (e. g. severe chest trauma or wounds)
• pneumothorax; patient undergoing ECMO
• patient with BMI ≥35 kg/m2
• hemodynamic instability with MAP \<60 mmHg despite vasopressors.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers Hospital

Angers, Maine et Loire, 49933, France

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

François Beloncle, MD

CONTACT

+33 241 35 58 65; francois.Francois.Beloncle@chu-angers.fr

UH Angers DRCI

CONTACT

+33 2 41 35 54 96; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Fifty patients will be enrolled, divided into 2 groups (n=26 each) according to a dynamic balanced sampling based on normalized respiratory system elastance (ERS) measured at PEEP 5 cmH2O with Vt 6-7 ml/kg PBW (\<2 cmH2O.mL-1.kg-1 vs. ≥2 cmH2O.mL-1.kg-1). Enrolment into each study group will be closed at 26 patients. Then, patients will be randomized and allocated to one of the following strategies: * Strategy A: PEEP 15 cmH2O → PEEP 5 cmH2O * Strategy B: PEEP 5 cmH2O → PEEP 15 cmH2O A parallel study will be conducted in Italy, to reach 50 more patients. Data will be shared between these two studies.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 13, 2022
• Study Start: February 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)