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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Recruiting
CT.gov ID
NCT05347563
Collaborator
(none)
200
1
35.4
5.6

Study Details

Study Description

Brief Summary

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,…)

Condition or Disease Intervention/Treatment Phase
  • Procedure: Electrical impedance tomography

Detailed Description

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure: Impact of Intervention
Actual Study Start Date :
Jun 18, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Children with acute respiratory failure

All patient with acute respiratory failure admitted to the Paediatric Intensive Care Unit requiring oxygenation or ventilatory support.

Procedure: Electrical impedance tomography
All change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…)

Outcome Measures

Primary Outcome Measures

  1. Distribution of Ventilation [up to 48 hours]

    Distribution of ventilation as determined by changes in impedence in region of interest

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • children < 18 years

  • Admitted to the PICU with acute respiratory failure

  • Monitoring with EIT

  • non opposition of parents or legal representative

Exclusion Criteria:
  • Monitor not available

  • contra indication to the use of thoracic belt

  • Children without

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paediatric intensive care Unit Bron Rhone France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Florent Baudin, MD, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05347563
Other Study ID Numbers:
  • 69HCL22_0111
  • 2022-A00505-38
First Posted:
Apr 26, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2022