- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06699017
Effect of Continuous Anterior Chest Compression on Ventilation/Perfusion Ratio and Hemodynamics (HemodyCACC)
Evaluation of the Effects of Continuous Anterior Chest Compression on Ventilation/Perfusion Ratios and Hemodynamics in SDRA
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:
- Anterior region overdistension,
- 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.
Recent data suggest that continuous anterior chest compression (CACC) could limit the overdistension of the anterior regions by decreasing the compliance of the anterior chest wall and thus the regional transpulmonary pressure, while promoting the redistribution of ventilation to the posterior territories.
The effects of CCAC on ventilation/perfusion ratios and hemodynamics are unknown.
Hypothesis/Objective :
The participants hypothesize that during ARDS, CCAC:
- Improves ventilation/perfusion ratios by decreasing both anterior territory dead space effect and posterior territory shunt,
- 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).
Objective:
Primary outcome :
To evaluate the effects of CCAC on ventilation/perfusion ratios during moderate to severe ARDS.
Secondary outcome :
To evaluate the effects of CCAC on hemodynamics : left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia.
Method In patient with moderate to severe ARDS, CACC is performed manually and the pressure applied will be maintained between 60 and 80 cmH2O.
Electrical impedance tomography of ventilation and perfusion will be used for the measurement of the percentage of areas with normal VA/Q ratios, areas of shunt and areas of dead space effect.
Left heart morphology, systolic and diastolic function, cardiac output, right heart morphology, systolic function, pulmonary hypertension, volemia will be evaluated by using echocardiography.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Creteil
-
Créteil, Creteil, France, 94010
- Henri Mondor Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient with moderate to severe ARDS under sedation andcontinuous curarization
|
CACC is performed manually and the pressure applied will be maintained between 60 and 80 cmH2O.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of areas with normal VA/Q ratios, areas of shunt and areas of dead space effect.
Time Frame: 28 days
|
demonstration that CACC may improve VA/Q ratio by using electrical impedance tomography
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CACC may induce a modification in cardiac output by decreasing right ventricular afterload
Time Frame: 28 days
|
measurement of cardiac output with echocardiography via : left ventricle outflow tract velocity time integral cm)
|
28 days
|
|
CACC may induce a modification in patient with right ventricular injury
Time Frame: 28 days
|
RV/LV : right ventricle end-diastolic ratio, to LV end-diastolic diameter ratio, sLV eccentricity index : systolic left ventricle eccentricity index; ACP : Acute cor pulmonale
|
28 days
|
|
CACC may induce a modification in right systolic function
Time Frame: 28 days
|
measurement of right systolic function paramaters : TAPSE (mm) , S' annular tricuspid wave (m/s), RVFAC (%)
|
28 days
|
|
CACC may induce a modification in left systolic function
Time Frame: 28 days
|
LVEF : left ventricular ejection fraction
|
28 days
|
|
CACC may induce a modification in ventilation distribution
Time Frame: 28 days
|
ventilation distribution antero-posterior and right/left, assessed by electrical impedance tomography
|
28 days
|
|
CACC may induce a modification in lung perfusion distribution
Time Frame: 28 days
|
lung perfusion distribution antero-posterior and right/left assessed by electrical impedance tomography
|
28 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP230065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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