NCT05347563

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,…)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jun 2022Jun 2027

First Submitted

Initial submission to the registry

April 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

April 12, 2022

Last Update Submit

January 21, 2026

Conditions

Acute Respiratory Failure

Keywords

Electrical impedance tomographyChildrenPediatric intensive care unit

Outcome Measures

Primary Outcomes (1)

  • Distribution of Ventilation

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

    up to 48 hours

Study Arms (2)

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

Group B (reference)

Group B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology.

Procedure: Electrical impedance tomography

Interventions

Electrical impedance tomographyPROCEDURE

All change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…)

Group AGroup B (reference)

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Femme Mère Enfant Service de néonatologie et réanimation néonatale

Bron, Rhone, 69500, France

RECRUITING

Hôpital Femme Mère Enfant Service de réanimation et d'urgence pédiatrique

Bron, Rhone, 69500, France

RECRUITING

Paediatric intensive care Unit

Bron, Rhone, 69500, France

RECRUITING

Hôpital Louis Pradel GHE - Réanimation Cardiaque Pédiatrique (U11)

Bron, Rhone, 69, France

RECRUITING

Related Publications (1)

  • Lauret V, Guerin C, Boussena S, De-Queiroz M, Bouvet L, Baudin F. Pressure support ventilation improves ventilation during inhalational induction of anesthesia in children: A pilot study. J Clin Anesth. 2025 Feb;101:111710. doi: 10.1016/j.jclinane.2024.111710. Epub 2024 Dec 17.

    PMID: 39693684DERIVED

Study Officials

  • Florent Baudin, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florent Baudin, MD

CONTACT

04 72 12 97 05florent.baudin@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 26, 2022

Study Start

June 18, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)