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

Not Applicable

Completed

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

• Registration Number: NCT04247477
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-30
• Study Start: 2020-09-22
• Primary Completion: 2021-04-08
• Study Completion: 2021-04-08
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-29
• Last Update Posted: 2022-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A-C-A-B	Ventilation strategy	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)
A-B-A-C	Ventilation strategy	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France