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

Primary Purpose

ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ventilation strategy
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS (Acute Respiratory Distress Syndrome) focused on measuring ARDS, EIT, PEEP titration, Mechanical Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A-B-A-C

A-C-A-B

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change in PaO2 (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance!

Secondary Outcome Measures

Change in PaCO2 (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Plateau pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Positive end expiratory pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Expiratory and inspiratory transpulmonary pressure (cmH2O)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Regional ventilation distribution (%)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Center of ventilation (%)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Overdistension and collapsus (%)
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)
As it is a physiological study, all the outcomes will be analyzed with the same importance
End expiratory lung volume (mL)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Blood pressure (mmHg)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Heart rate (bpm)
As it is a physiological study, all the outcomes will be analyzed with the same importance
Cardiac output (L/min)
As it is a physiological study, all the outcomes will be analyzed with the same importance

Full Information

First Posted
January 21, 2020
Last Updated
July 29, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04247477
Brief Title
Comparison of Different PEEP Titration Strategies Using Electrical Impedance Tomography in Patients With ARDS
Acronym
DELTA
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS (Acute Respiratory Distress Syndrome), Electrical Impedance Tomography (EIT), Positive End Expiratory Pressure (PEEP), Acute Lung Injury
Keywords
ARDS, EIT, PEEP titration, Mechanical Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-B-A-C
Arm Type
Experimental
Arm Description
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)
Arm Title
A-C-A-B
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Ventilation strategy
Intervention Description
Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)
Primary Outcome Measure Information:
Title
Change in PaO2 (mmHg)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance!
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Secondary Outcome Measure Information:
Title
Change in PaCO2 (mmHg)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Plateau pressure (cmH2O)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Positive end expiratory pressure (cmH2O)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Expiratory and inspiratory transpulmonary pressure (cmH2O)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Regional ventilation distribution (%)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Center of ventilation (%)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Overdistension and collapsus (%)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Global and regional end expiratory lung impedance changes (IU)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
End expiratory lung volume (mL)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Blood pressure (mmHg)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Heart rate (bpm)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes
Title
Cardiac output (L/min)
Description
As it is a physiological study, all the outcomes will be analyzed with the same importance
Time Frame
Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49100
Country
France

12. IPD Sharing Statement

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

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