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

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS, Human
• Intervention / Treatment: Other: PEEP and Tidal Volume Titration

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francois Beloncle, MD-PhD; Phone Number: +33 2 41 35 58 65; Email: francois.beloncle@univ-angers.fr

Study Locations

• France
  • Angers, France, 49000
    • Recruiting
    • Chu Angers
    • Contact: François Beloncle, MD-PhD; Phone Number: +33241353815; Email: francois.beloncle@univ-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilation strategy failure	Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: 2019-A03242-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No