Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study

University Hospital, Angers1 site in 1 country20 target enrollmentJune 30, 2020

ConditionsARDS

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ARDS
Sponsor: University Hospital, Angers
Enrollment: 20
Locations: 1
Primary Endpoint: change of PaO2 (mmHg)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the COMIX-R study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit

Registry

clinicaltrials.gov

Start Date

June 30, 2020

End Date

October 26, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Angers

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 years or older
•Invasive mechanical ventilation on tracheal probe
•Acute respiratory distress syndrome, as defined by Berlin conference consensus, during hospitalization in intensive care,
•Recovery phase of acute respiratory distress syndrome: spontaneous ventilation representing from 20 to 30% of ventilation in APRV mode.
•No severe acidosis (pH\> 7.30)
•Patient affiliated to or beneficiary of a health care plan
•Express consent of the patient or his/her SDM

Exclusion Criteria

•Pneumothorax
•Contraindication to the insertion of a nasogastric tube with an esophageal balloon
•Contraindication to the use of Electrical impedance tomography (pacemaker)
•Pregnancy, lactating or parturient woman

Outcomes

Primary Outcomes

change of PaO2 (mmHg)

Time Frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Arterial partial pressure of dioxygen Of note: As it is a physiological study, all the primary and secondary outcomes will be analyzed with the same importance.

Secondary Outcomes

-Tidal volume variability(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-Respiratory rate variability(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-Respiratory comfort(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-Pressure time product (PTP)(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
MAP(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-Patient-ventilator asynchronies(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-expiratory and inspiratory transpulmonary pressure(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-ventilation distribution in the lungs(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-Work of breathing (WOB)(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-P0.1(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
HR(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-other arterial parameters of hematosis(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)
-PEEPi(15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes)