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

Sponsor

University Hospital, Angers (Other)

Overall Status

Recruiting

CT.gov ID

NCT05337059

Collaborator

(none)

Enrollment

Location

Arm

24.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS, Human	Other: PEEP and Tidal Volume Titration	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

feasibility, monocentric, prospective studyfeasibility, monocentric, prospective study

Masking:

None (Open Label)

Primary Purpose:

Treatment

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..

Actual Study Start Date :

Mar 30, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transpulmonary based ventilation strategy 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 PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures

Arm

Intervention/Treatment

Experimental: Transpulmonary based ventilation strategy

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

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

Outcome Measures

Primary Outcome Measures

Ventilation strategy failure [48 hours]
Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)

Secondary Outcome Measures

Short term physiologicals effects on hemodynamics [45 minutes]
Cardiac index assed by Echocardiography (L/min/m^2)
All-cause mortality at day 28 [28 days]
All-cause mortality
Ventilator-free days at day 28 [28 days]
Number of alive ventilator free days
Short term physiologicals effects on respiratory mechanics [45 minutes]
recruited lung volume (mL)
Short term physiologicals effects on gas exchange [45 minutes]
PaO2/FiO2 ratio (mmHg)
Short term physiologicals effects on gas exchange [45 minutes]
VD/VT
Short term physiologicals effects on gas exchange [45 minutes]
PaCO2 (mmHg)
Short term physiologicals effects on respiratory mechanics [45 minutes]
distribution of ventilation assed by electrical impedance tomography (COV, %)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Angers	Angers		France	49000

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05337059

Other Study ID Numbers:

2019-A03242-55

First Posted:

Apr 20, 2022

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Study Results

No Results Posted as of Apr 20, 2022