DELTA: Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS

Sponsor

University Hospital, Angers (Other)

Overall Status

Completed

CT.gov ID

NCT04247477

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS (Acute Respiratory Distress Syndrome) Electrical Impedance Tomography (EIT) Positive End Expiratory Pressure (PEEP) Acute Lung Injury	Other: Ventilation strategy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 22, 2020

Actual Primary Completion Date :

Apr 8, 2021

Actual Study Completion Date :

Apr 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A-B-A-C Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) - Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C)	Other: Ventilation strategy Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)
Experimental: A-C-A-B Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) - Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B)	Other: Ventilation strategy Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)

Arm

Intervention/Treatment

Experimental: A-B-A-C

Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B) - Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C)

Other: Ventilation strategy

Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)

Experimental: A-C-A-B

Four consecutive steps (45 min per step) are tested in the following order: Peep titration strategy according to Express method (A) - Peep titration strategy according to estimation of lung inhomogeneity (C) - Peep titration strategy according to Express method (A) - Peep titration strategy according to overdistension and collapse estimation (B)

Other: Ventilation strategy

Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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