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NCT04196738 Clinical Trial

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

ARDS Clinical Trial

— COMIX-R  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04196738
Other study ID # 49RC19_0195
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2020
Est. completion date October 26, 2022

Study information
Verified date January 2024
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 26, 2022
Est. primary completion date October 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France University hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 -Respiratory rate variability variability of rate (per minute) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -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
Secondary -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
Secondary -other arterial parameters of hematosis pH, PaO2, PaCo2 (mmHg) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -Work of breathing (WOB) calculated with esophageal pressure (Kg/m) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -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
Secondary -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
Secondary -PEEPi intrinsic positive end-expiratory pressure (cm H20) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary MAP mean arterial pressure 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary HR heart rate (beats per minute) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -Respiratory comfort visual analogic scale 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -Patient-ventilator asynchronies numbers of asynchronies analyzed on screen 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary -Tidal volume variability variability of Tidal volume (mL) 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
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