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

NCT ID: NCT05578742

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2026-09-30

Brief Summary

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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).

Detailed Description

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Acute Respiratory Distress Syndrome (ARDS) is characterized by hypoxemia caused by inflammatory lung injury. Recent studies showed an important variability in ARDS phenotypes . The recent COVID-19 crisis highlighted the presence of ARDS patients with severe hypoxemia and normal respiratory system compliance, and retrospective series confirmed the existence of this atypical ARDS pattern also in non-COVID etiologies.

The dissociation between mechanics and hypoxemia may be related to a specific diversity in the pattern of ventilation-perfusion matching (V/Q matching) among patients with normal compliance and ARDS. In patients with low compliance, V/Q mismatch may be characterized by right-to-left shunt, secondary to collapse of the gravity-dependent regions; while, in patients with normal compliance, V/Q mismatch may show a redistribution of blood flow to hypo-ventilated lung areas by larger dead space and impaired hypoxic vasoconstriction.

These differences may also influence the response to PEEP in terms of gas exchange and lung protection . It may also explain the failure for high PEEP levels to improve significantly mortality in the global ARDS population (i.e., with patients' selection only based on hypoxemia).

Electrical Impedance Tomography (EIT) is a device allowing to assess ventilation and perfusion distribution. Thus, EIT can be used to evaluate global and regional V/Q matching, and could be used to understand mechanisms of hypoxemia, especially in patients with normal mechanics and ARDS.

The aim of this study is to assess V/Q matching according to these different ARDS phenotypes, and to evaluate the effects of PEEP in each one.

Conditions

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ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Strategy A: PEEP 15 cmH2O → PEEP 5 cmH2O

Group Type EXPERIMENTAL

PEEP decrease

Intervention Type PROCEDURE

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

Strategy B: PEEP 5 cmH2O → PEEP 15 cmH2O

Group Type ACTIVE_COMPARATOR

PEEP increase

Intervention Type PROCEDURE

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

Interventions

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PEEP increase

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

Intervention Type PROCEDURE

PEEP decrease

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Angers Hospital

Angers, Maine et Loire, France

Site Status RECRUITING

Countries

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France

Central Contacts

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François Beloncle, MD

Role: CONTACT

+33 241 35 58 65

UH Angers DRCI

Role: CONTACT

+33 2 41 35 54 96

Facility Contacts

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François Beloncle, MD

Role: primary

+33 2 41 58 65

UH Angers DRCI UH Angers

Role: backup

+33 5 41 35 54 96

Other Identifiers

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2022-A00649-34

Identifier Type: -

Identifier Source: org_study_id

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