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

NCT ID: NCT04247477

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2021-04-08

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Ventilation strategy

Intervention Type OTHER

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

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)

Group Type EXPERIMENTAL

Ventilation strategy

Intervention Type OTHER

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

Interventions

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Ventilation strategy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status

Countries

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France

Other Identifiers

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49RC19_0249

Identifier Type: -

Identifier Source: org_study_id

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