Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.
- Conditions
- ARDS
- Interventions
- Other: ventilation strategy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
- Arm && Interventions
Group Intervention Description Dual Mode first ventilation strategy Four consecutive steps (45 min per step) in the following order: APRV (A), Dual Mode (B) , APRV (A) and VAC (C). (ABAC) VAC fist ventilation strategy Four consecutive steps (45 min per step) in the following order: APRV (A), VAC (C) , APRV (A) and Dual Mode (B). (ACAB)
- 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