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

NCT04247477 | Completed DMC

• 1 other identifier: 49RC19_0249
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

ARDS; EIT; PEEP titration; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in PaCO2 (mmHg)

  Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

• Plateau pressure (cmH2O)

  Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

• Positive end expiratory pressure (cmH2O)

  Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

• Expiratory and inspiratory transpulmonary pressure (cmH2O)

  Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

• Regional ventilation distribution (%)

  Time : 0 ; 45 minutes ; 90 minutes ; 135 minutes ; 180 minutes

Study Arms (2)

A-B-A-C

EXPERIMENTAL

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

A-C-A-B

EXPERIMENTAL

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

Interventions

Ventilation strategy OTHER

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

A-B-A-C; A-C-A-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49100, France

Location

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 30, 2020
• Study Start: September 22, 2020
• Primary Completion: April 8, 2021
• Study Completion: April 8, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

FR (1)