Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation. (COMIX-R)

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

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

Study Overview

• Status: Completed
• Conditions: ARDS
• Intervention / Treatment: Other: ventilation strategy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • University Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Mode first; Four consecutive steps (45 min per step) in the following order: APRV (A), Dual Mode (B) , APRV (A) and VAC (C). (ABAC)	Other: ventilation strategy; Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation
Experimental: VAC fist; Four consecutive steps (45 min per step) in the following order: APRV (A), VAC (C) , APRV (A) and Dual Mode (B). (ACAB)	Other: ventilation strategy; Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of PaO2 (mmHg)	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.	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
-Respiratory rate variability	variability of rate (per minute)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-expiratory and inspiratory transpulmonary pressure	calculated with the esophageal pressure (cm H20)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-ventilation distribution in the lungs	Electrical impedance tomography (EIT) assess distribution of tidal volume and of end-expiratory lung volume (EELV) (delta Z, IU)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-other arterial parameters of hematosis	pH, PaO2, PaCo2 (mmHg)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Work of breathing (WOB)	calculated with esophageal pressure (Kg/m)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Pressure time product (PTP)	-Pressure time product (PTP) calculated with esophageal pressure (cmH2O.s.min-1)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-P0.1	pressure measured during the first 100 ms after an occlusion (cm H20)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-PEEPi	intrinsic positive end-expiratory pressure (cm H20)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
MAP	mean arterial pressure	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
HR	heart rate (beats per minute)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Respiratory comfort	visual analogic scale	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Patient-ventilator asynchronies	numbers of asynchronies analyzed on screen	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Tidal volume variability	variability of Tidal volume (mL)	15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Francois BELONCLE, CCU-AH, Angers teatching hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 49RC19_0195

Drug and device information, study documents

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