NCT05876468

Brief Summary

The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.

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 Apr 2022

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

Study Start

First participant enrolled

April 13, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2023

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

August 8, 2022

Last Update Submit

February 9, 2026

Conditions

Keywords

ARDS : Acute Respiratory Distress SyndromeCACC : Continuous Anterior Chest CompressionVILI : Ventilator-Induced Lung InjuryARDS,Human: Adult Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • The end inspiratory transpulmonary pressure (PL-insp) in centimetre of water

    The transpulmonary pressure will be measured by using an esophageal catheter connected to a differential pressure transducer. The PL-insp will be calculated using the ratio between the elastance of the lung (El) and of the respiratory system (Ers) expressed in centimetre of water thanks to this formula PL-insp = Plateau pressure x (El/Ers). The PL-insp between the different protocol conditions will be compared (After 16 hours of prone position, in supine position, 15mn after CACC with a pressure equal to the one observed in the prone position, 15mn after CACC with a pressure set at 60 - 80 cmH20, 15mn after taking off the CACC in supine position ). CACC will be considered protective if there is a decrease in Pl-insp.

    Through study completion (up to 6 hours)

Secondary Outcomes (8)

  • Regional pulmonary compliances in centimetre of water

    Through study completion (up to 6 hours)

  • Lung mechanics : Airways pressure, Flow curves and Esophageal pressure

    Through study completion (up to 6 hours)

  • Pulmonary ventilation distribution in percentage

    Through study completion (up to 6 hours)

  • Recruitment-to-inflation (R/I) ratio

    Through study completion (up to 6 hours)

  • Hemodynamics

    Through study completion (up to 6 hours)

  • +3 more secondary outcomes

Study Arms (1)

A description of each arm of the clinical trial that indicates its role in the clinical trial

EXPERIMENTAL

Arm 1 Description: The study will consitent of recording the measurments of ventilatory settings, respiratory mechanics, flow and pressure curves, gaz exchange, haemodynamics and ventilation distribution in 5 consecutive conditions in adult patients with moderate to severe ARDS : * After 16 hours of prone position * In supine position 1 hour after the prone position * 15mn after CACC with a pressure equal to the one observed in the prone position * 15mn after CACC with a pressure set at 60 - 80 cmH20 * 15mn after taking of the CACC

Device: Continuous anterior chest compression

Interventions

Patients with severe to moderate ARDS who were placed in prone position by the attending physician : * First CACC : the applied pressure is equal to the one observed in the prone position * Second CACC : The applied pressure is set at 60 - 80 cmH20

A description of each arm of the clinical trial that indicates its role in the clinical trial

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 ans
  • Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio \<= 200 mmHg)
  • The patent must be sedated and paralyzed
  • Informed consent from patient or family members

You may not qualify if:

  • Extracorporeal membrane oxygenation (ECMO)
  • Pneumothorax
  • Thoracic trauma during the last 3 months
  • Refractory shock
  • Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement)
  • Pregnancy
  • Any contra-indication to esophageal manometry (less than one month esophagus surgery, bronchopleural or esotracheal fistula, latex allergy)
  • No social care
  • Adults under Guardianship, curatorship or protection of the court

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Guillaume CARTEAUX, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Clinical trials with a single arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

May 25, 2023

Study Start

April 13, 2022

Primary Completion

June 25, 2023

Study Completion

June 25, 2023

Last Updated

February 11, 2026

Record last verified: 2026-01

Locations