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NCT05347563 Clinical Trial

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

Acute Respiratory Failure Clinical Trial

— PELUCHE1  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05347563
Other study ID # 69HCL22_0111
Secondary ID 2022-A00505-38
Status Recruiting
Phase
First received
Last updated
Start date June 18, 2022
Est. completion date June 2025

Study information
Verified date March 2024
Source Hospices Civils de Lyon
Contact Florent Baudin, MD
Phone 04 72 12 97 05
Email florent.baudin@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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,…)

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France Paediatric intensive care Unit Bron Rhone

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distribution of Ventilation Distribution of ventilation as determined by changes in impedence in region of interest up to 48 hours
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