Acute Respiratory FailurePELUCHE1NCT05347563
Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure
An observational study of Acute Respiratory Failure, run by Hospices Civils de Lyon at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 18 Jun 2022to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- With general anesthesia and mechanical ventilation
- Monitoring with EIT
- non opposition of parents or legal representative
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hôpital Femme Mère Enfant Service de néonatologie et réanimation néonatale
Bron, Rhone, 69500
Dreyfus Lélia, Dr, 0472396438 ext. +33, lelia.dreyfus@chu-lyon.fr
- Recruiting
Hôpital Femme Mère Enfant Service de réanimation et d'urgence pédiatrique
Bron, Rhone, 69500
BOUVET Lionel, Pr, 04 72 12 97 63 ext. +33, lionel.bouvet@chu-lyon.fr
- Recruiting
Paediatric intensive care Unit
Bron, Rhone, 69500
Florent BAUDIN, MD, 04 72 12 97 05 ext. +33, florent.baudin@chu-lyon.fr
- Recruiting
Hôpital Louis Pradel GHE - Réanimation Cardiaque Pédiatrique (U11)
Bron, Rhone, 69
Sylvain RAIMBAULT, 04 26 73 93 48 ext. +33, sylvain.raimbault@chu-lyon.fr
About this study
Official title: 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,…)
Read the detailed description
Children with acute respiratory failure admitted to the PICU (pediatric intensive care unit)
- Conditions
- Acute Respiratory Failure
- Being tested
- Electrical impedance tomography
- Keywords
- Electrical impedance tomography, Children, Pediatric intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyProcedure or surgery
All change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Electrical impedance tomography | |
| Group B (reference) | Group B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology. Receives: Procedure: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of Ventilation
Distribution of ventilation as determined by changes in impedence in region of interest
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start18 Jun 2022
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Baudin, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347563
- Sponsor's protocol ID
- 69HCL22_0111
- Other IDs
- 2022-A00505-38
- Acronym
- PELUCHE1
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39693684
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Ventilation Distribution With Electrical Impedance Tomography for Paediatric Respiratory Failure: Impact of Intervention
- ClinicalTrials.gov ID
- NCT05347563
- Acronym / sponsor ID
- PELUCHE1 / 69HCL22_0111
- Conditions
- Acute Respiratory Failure
- Keywords
- Electrical impedance tomography, Children, Pediatric intensive care unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,…)
Detailed description
Children with acute respiratory failure admitted to the PICU (pediatric intensive care unit)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Electrical impedance tomographygroup 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) | – | Procedure: Electrical impedance tomographyGroup B (reference): Patient under general anesthesia with mechanical ventilation without respiratory pathology. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical impedance tomographyAll change in ventilator settings (mode, tidal volume or inspiratory pressure, Peep, recruitment…) | Procedure or surgery | Group A, Group B (reference) |
Primary outcome
Distribution of Ventilation
Time frame: up to 48 hours
Distribution of ventilation as determined by changes in impedence in region of interest
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 39693684Lauret 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florent Baudin, MD principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent Baudin, MD (04 72 12 97 05 ext. +33, florent.baudin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of Ventilation (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347563, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.