Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.

Not Applicable

Completed

• Conditions: ARDS

• Registration Number: NCT04196738
• Lead Sponsor: University Hospital, Angers

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Study Start: 2020-06-30
• Primary Completion: 2022-10-26
• Study Completion: 2022-10-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
change of PaO2 (mmHg)	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 Outcome Measures

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

Trial Locations

Locations (1)

University hospital; 🇫🇷 Angers, France