NCT05337059

Brief Summary

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

March 29, 2022

Last Update Submit

April 9, 2026

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

  • Ventilation strategy failure

    Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)

    48 hours

Secondary Outcomes (8)

  • Short term physiologicals effects on hemodynamics

    45 minutes

  • All-cause mortality at day 28

    28 days

  • Ventilator-free days at day 28

    28 days

  • Short term physiologicals effects on respiratory mechanics

    45 minutes

  • Short term physiologicals effects on gas exchange

    45 minutes

  • +3 more secondary outcomes

Study Arms (1)

Transpulmonary based ventilation strategy

EXPERIMENTAL

PEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively.

Other: PEEP and Tidal Volume Titration

Interventions

PEEP and Tidal Volume TitrationOTHER

PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures

Transpulmonary based ventilation strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older
  • Moderate to severe ARDS
  • Written informed consent obtained from patient' surrogates

You may not qualify if:

  • Pneumothorax
  • Known pregnancy
  • Contraindication to electrical impedance tomography or esophageal pressure measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: feasibility, monocentric, prospective study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 20, 2022

Study Start

March 30, 2022

Primary Completion

March 4, 2026

Study Completion

April 1, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)