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

Primary Purpose

ARDS, Human

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PEEP and Tidal Volume Titration
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu AngersRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transpulmonary based ventilation strategy

Arm Description

PEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 29, 2022
Last Updated
April 14, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT05337059
Brief 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.
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..
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
feasibility, monocentric, prospective study
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transpulmonary based ventilation strategy
Arm Type
Experimental
Arm Description
PEEP and tidal volume will be set to target expiratory and inspiratory transpulmonary pressures of 0 and 20 cmH2O, respectively.
Intervention Type
Other
Intervention Name(s)
PEEP and Tidal Volume Titration
Intervention Description
PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures
Primary Outcome Measure Information:
Title
Ventilation strategy failure
Description
Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Short term physiologicals effects on hemodynamics
Description
Cardiac index assed by Echocardiography (L/min/m^2)
Time Frame
45 minutes
Title
All-cause mortality at day 28
Description
All-cause mortality
Time Frame
28 days
Title
Ventilator-free days at day 28
Description
Number of alive ventilator free days
Time Frame
28 days
Title
Short term physiologicals effects on respiratory mechanics
Description
recruited lung volume (mL)
Time Frame
45 minutes
Title
Short term physiologicals effects on gas exchange
Description
PaO2/FiO2 ratio (mmHg)
Time Frame
45 minutes
Title
Short term physiologicals effects on gas exchange
Description
VD/VT
Time Frame
45 minutes
Title
Short term physiologicals effects on gas exchange
Description
PaCO2 (mmHg)
Time Frame
45 minutes
Title
Short term physiologicals effects on respiratory mechanics
Description
distribution of ventilation assed by electrical impedance tomography (COV, %)
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francois Beloncle, MD-PhD
Phone
+33 2 41 35 58 65
Email
francois.beloncle@univ-angers.fr
Facility Information:
Facility Name
Chu Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Beloncle, MD-PhD
Phone
+33241353815
Email
francois.beloncle@univ-angers.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this 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.

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