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NCT05337059 Clinical Trial

Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.

ARDS, Human Clinical Trial

Official title:
Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05337059
Other study ID # 2019-A03242-55
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date April 2024

Study information
Verified date April 2022
Source University Hospital, Angers
Contact Francois Beloncle, MD-PhD
Phone +33 2 41 35 58 65
Email francois.beloncle@univ-angers.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.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.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date April 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Moderate to severe ARDS - Written informed consent obtained from patient' surrogates Exclusion Criteria: - Pneumothorax - Known pregnancy - Contraindication to electrical impedance tomography or esophageal pressure measurements

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• PEEP and Tidal Volume Titration
PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures

Locations
Country Name City State
France Chu Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ventilation strategy failure Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia) 48 hours
Secondary Short term physiologicals effects on hemodynamics Cardiac index assed by Echocardiography (L/min/m^2) 45 minutes
Secondary All-cause mortality at day 28 All-cause mortality 28 days
Secondary Ventilator-free days at day 28 Number of alive ventilator free days 28 days
Secondary Short term physiologicals effects on respiratory mechanics recruited lung volume (mL) 45 minutes
Secondary Short term physiologicals effects on gas exchange PaO2/FiO2 ratio (mmHg) 45 minutes
Secondary Short term physiologicals effects on gas exchange VD/VT 45 minutes
Secondary Short term physiologicals effects on gas exchange PaCO2 (mmHg) 45 minutes
Secondary Short term physiologicals effects on respiratory mechanics distribution of ventilation assed by electrical impedance tomography (COV, %) 45 minutes
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