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

Comparison of Different Positive End-expiratory Pressure Titration Strategies Using ELectrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome : the DELTA Physiological Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury; ARDS (Acute Respiratory Distress Syndrome); Positive End Expiratory Pressure (PEEP); Electrical Impedance Tomography (EIT)
• Intervention / Treatment: Other: Ventilation strategy

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PaO2 (mmHg)	As it is a physiological study, all the outcomes will be analyzed with the same importance!	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in PaCO2 (mmHg)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Plateau pressure (cmH2O)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Positive end expiratory pressure (cmH2O)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Expiratory and inspiratory transpulmonary pressure (cmH2O)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Regional ventilation distribution (%)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Center of ventilation (%)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Overdistension and collapsus (%)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Global and regional end expiratory lung impedance changes (IU)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
End expiratory lung volume (mL)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Blood pressure (mmHg)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Heart rate (bpm)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Cardiac output (L/min)	As it is a physiological study, all the outcomes will be analyzed with the same importance	Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2020
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): April 8, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: ARDS; Mechanical Ventilation; EIT; PEEP titration
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: 49RC19_0249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No