Clinical trial NCT04196738: Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.
Official title: Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: patients exposed to 3 ventilatory mode in 2 different possible orders
Primary purpose: OTHER

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


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

Primary outcomes:
measure: change of PaO2 (mmHg)
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary outcomes:
measure: -Respiratory rate variability
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -expiratory and inspiratory transpulmonary pressure
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -ventilation distribution in the lungs
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -other arterial parameters of hematosis
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -Work of breathing (WOB)
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -Pressure time product (PTP)
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -P0.1
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -PEEPi
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: MAP
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: HR
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -Respiratory comfort
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -Patient-ventilator asynchronies
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
measure: -Tidal volume variability
timeFrame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital
Study officials:
affiliation: Angers teatching hospital
name: Francois BELONCLE, CCU-AH
role: PRINCIPAL_INVESTIGATOR
References: