NCT06699017

Brief Summary

Intro: The mortality of acute respiratory distress syndrome (ARDS) remains high (40%), and may be aggravated by ventilation-induced lung injury (VILI), the main mechanisms of which are:

  1. 1.Anterior region overdistension,
  2. 2.Atelectrauma in the posterior regions. Positive expiratory pressure (PEEP) adjusted on the ventilator during ARDS aims to recruit posterior pulmonary territories in order to limit atelectrauma but is accompanied by a concomitant risk of overdistension of anterior territories.
  3. 3.Improves ventilation/perfusion ratios by decreasing both anterior territory dead space effect and posterior territory shunt,
  4. 4.Induce an improvement in cardiac output by decreasing right ventricular afterload (decrease in capillary compression related to the overdistension of the anterior territories and decrease in hypoxic vasoconstriction of the condensed territories).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

February 28, 2023

Last Update Submit

January 14, 2026

Conditions

Keywords

ARDScardiac outputventilation perfusion ratio

Outcome Measures

Primary Outcomes (1)

  • percentage of areas with normal VA/Q ratios, areas of shunt and areas of dead space effect.

    demonstration that CACC may improve VA/Q ratio by using electrical impedance tomography

    28 days

Secondary Outcomes (6)

  • CACC may induce a modification in cardiac output by decreasing right ventricular afterload

    28 days

  • CACC may induce a modification in patient with right ventricular injury

    28 days

  • CACC may induce a modification in right systolic function

    28 days

  • CACC may induce a modification in left systolic function

    28 days

  • CACC may induce a modification in ventilation distribution

    28 days

  • +1 more secondary outcomes

Study Arms (1)

Patient with moderate to severe ARDS under sedation andcontinuous curarization

EXPERIMENTAL

Patient with moderate to severe ARDS under sedation andcontinuous curarization

Other: Continuous anterior chest compression

Interventions

CACC is performed manually and the pressure applied will be maintained between 60 and 80 cmH2O.

Patient with moderate to severe ARDS under sedation andcontinuous curarization

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • ARDS moderate to severe according to the Berlin criteria
  • Patient receiving continuous sedation and curarization
  • Free and informed consent from the patient or family member

You may not qualify if:

  • Pregnancy
  • Adult patient subject to a legal protection measure (tutor, curator, etc.)
  • Patients with a pacemaker, automatic implantable cardioverter defibrillator,
  • Contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
  • Undrained pneumothorax, bronchopleural fistula
  • Hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor hospital

Créteil, Creteil, 94010, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patient with moderate to severe ARDS under sedation and curarization keep on going
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2023

First Posted

November 21, 2024

Study Start

February 28, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Locations