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NCT04247477 Clinical Trial

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

Acute Lung Injury Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04247477
Other study ID # 49RC19_0249
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 22, 2020
Est. completion date April 8, 2021

Study information
Verified date July 2022
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date April 8, 2021
Est. primary completion date April 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Ventilation strategy
Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)

Locations
Country Name City State
France CHU Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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