Acute Lung Injury, ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP)
Conditions
Keywords
ARDS, EIT, PEEP titration, Mechanical Ventilation
Brief summary
The aim of the this study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit. Two of those strategies are based on electrical impedance tomography (EIT) monitoring.
Interventions
OTHERVentilation strategy
Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
We use a crossover sequential model, with all 3 strategies tested in both arms. A reference strategy, based on the Express method (PEEP level adjusted to reach a plateau pressure of 28-30 cmH2O), is applied at the begining of the study and during a wash-out period (between the 2 periods of application of the 2 EIT-based strategies). The 2 EIT-based strategies are applied in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with moderate to severe ARDS, defined by the Berlin consensus, at 12 to 48h from diagnosis * PaO2/FiO2 ratio \< 150 mmHg * Patient affiliated to or beneficiary of a health care plan * Consent obtained from patient's SDM
Exclusion criteria
* Pneumothorax * Contraindication to the insertion of a nasogastric tube with an esophageal balloon * Contraindication to the use of Electrical impedance tomography * Pregnancy, lactating or parturient woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PaO2 (mmHg) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance! |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plateau pressure (cmH2O) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Positive end expiratory pressure (cmH2O) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Expiratory and inspiratory transpulmonary pressure (cmH2O) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Regional ventilation distribution (%) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Center of ventilation (%) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Change in PaCO2 (mmHg) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Global and regional end expiratory lung impedance changes (IU) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| End expiratory lung volume (mL) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Blood pressure (mmHg) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Heart rate (bpm) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Cardiac output (L/min) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
| Overdistension and collapsus (%) | Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes | As it is a physiological study, all the outcomes will be analyzed with the same importance |
Countries
France
Outcome results
None listed