Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS (REPEIT)

November 19, 2024 updated by: Centre Hospitalier Saint Joseph Saint Luc de Lyon

Impact of Belt Position on the Results of PEEP Titration by Electrical Impedance Tomography During Acute Respiratory Distress Syndrome

ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
  • Criteria for moderate to severe ARDS for less than 72 hours
  • Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
  • Consent of next of kin

Exclusion Criteria:

  • Age < 18 years
  • ECMO
  • Pneumothorax
  • Pacemaker or implantable defibrillator
  • Chest trauma in the last 3 months
  • Skin peeling (Burned, Lyell)
  • Intracranial hypertension
  • Uncontrolled shock (noradrenaline >5 mg/h)
  • Pregnant woman
  • Adult patient protected within the meaning of the law
  • Lack of social security

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: PEEP titrations
Device: EIT
Two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height (2nd intercostal space or 5th intercostal space). The order will be drawn at random.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the position of the electrode belt on the results of PEEP titration by EIT.
Time Frame: Day 0
Optimal PEEP determined by PEEP titration using the crossing point method.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS
Time Frame: Day 0
Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median
Day 0
Factors associated with a discordance between PEPEIT and PEPCRS
Time Frame: Day 0
Variability of the impedance variation during insufflation of the tidal volume ("tidal impedance variation) during titration measured by the relative interquartile coefficient (Q3-Q1)/median
Day 0
Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume
Time Frame: Day 0
Regional ventilation delay (RVD)
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REPEIT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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