ARDS
Conditions
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
Interventions
OTHERventilation strategy
Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
patients exposed to 3 ventilatory mode in 2 different possible orders
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| -PEEPi | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | intrinsic positive end-expiratory pressure (cm H20) |
| MAP | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | mean arterial pressure |
| HR | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | heart rate (beats per minute) |
| -Respiratory comfort | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | visual analogic scale |
| -Patient-ventilator asynchronies | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | numbers of asynchronies analyzed on screen |
| -Respiratory rate variability | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | variability of rate (per minute) |
| -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) |
| -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) |
| -other arterial parameters of hematosis | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | pH, PaO2, PaCo2 (mmHg) |
| -Work of breathing (WOB) | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | calculated with esophageal pressure (Kg/m) |
| -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) |
| -Tidal volume variability | 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes | variability of Tidal volume (mL) |
| -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) |
Countries
France
Outcome results
None listed