Clinical trial NCT04247477: Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS
Official title: Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Electrical Impedance Tomography (EIT)
Positive End Expiratory Pressure (PEEP)
Acute Lung Injury
Keywords: ARDS
EIT
PEEP titration
Mechanical Ventilation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-01-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in PaO2 (mmHg)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Secondary outcomes:
measure: Change in PaCO2 (mmHg)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Plateau pressure (cmH2O)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Positive end expiratory pressure (cmH2O)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Expiratory and inspiratory transpulmonary pressure (cmH2O)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Regional ventilation distribution (%)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Center of ventilation (%)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Overdistension and collapsus (%)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Global and regional end expiratory lung impedance changes (IU)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: End expiratory lung volume (mL)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Blood pressure (mmHg)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Heart rate (bpm)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
measure: Cardiac output (L/min)
timeFrame: Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
References: