Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure (PELUCHE1)

March 15, 2024 updated by: Hospices Civils de Lyon

Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure: Impact of Intervention

Electrical impedance tomography (EIT) is a non-invasive, bedside monitoring technique that provides continuous, real-time information about the regional distribution of the ventilation.

There are very few data in children admitted to the PICU (pediatric intensive care unit) and the aim of the study is to describe the distribution of the ventilation in children with acute respiratory failure and to study the impact of the interventions in the PICU (change in ventilatory settings, change in position, suction, respiratory kinesiotherapy,…)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Children with acute respiratory failure admitted to the PICU (pediatric intensive care unit)

Study Type

Observational

Enrollment (Estimated)

250

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 Locations

  • France
    • Rhone
      • Bron, Rhone, France, 69500
        • Recruiting
        • Paediatric intensive care Unit
        • Contact:

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

250 Childrens group A: Patient < 18 years old admitted to a continuous monitoring unit - resuscitation for acute respiratory failure regardless of the ventilation modality and benefiting from TIE monitoring Group B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology.

Description

Inclusion Criteria:

Groupe A

  • children < 18 years
  • Admitted to the PICU with acute respiratory failure
  • Monitoring with EIT
  • non opposition of parents or legal representative Groupe B
  • children < 18 years
  • With general anesthesia and mechanical ventilation
  • Monitoring with EIT
  • non opposition of parents or legal representative

Exclusion Criteria:

  • Monitor not available
  • contra indication to the use of thoracic belt
  • Intraoperative period with use of electrocautery
  • Child not affiliated to a social security system and under protective measures legal

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
group A: Patient < 18 years old admitted to a continuous monitoring unit - resuscitation for acute respiratory failure regardless of the ventilation modality and benefiting from TIE monitoring
Procedure: Electrical impedance tomography
All change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…)
Group B (reference)
Group B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology.
Procedure: Electrical impedance tomography
All change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of Ventilation
Time Frame: up to 48 hours
Distribution of ventilation as determined by changes in impedence in region of interest
up to 48 hours

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Florent Baudin, MD, Hospices Civils 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 (Actual)

June 18, 2022

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_0111
  • 2022-A00505-38 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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