BronchiolitisWRAPITISNCT06083077
Chest and Abdominal Wall Strapping in Infant With Bronchiolitis
A study testing Chest wall strapping in people with Bronchiolitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress. The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Chest wall strapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2023to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant < 6 months
- Admitted to the PICU for less than 48 hours
- With a diagnosis of bronchiolitis
- With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support
- With a naso or oro gastric tube for feeding
- With written informed consent from parents or legal guardians
Who cannot join
- Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease
- Contraindication to the use of a gastric tube
- recent abdominal or thoracic surgery
- investigator able to perform physiological recording not available
- Patient who is not affiliated (or does not benefit from) to a national social security system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study
Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress.
The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction.
Infant < 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.
- Conditions
- Bronchiolitis
- Being tested
- Chest wall strapping
- Keywords
- Bronchiolitis, Work of breathing, Non-invasive ventilation, Infant
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall strappingOther
An elastic band (6 cm wide) is placed around the lower part of the chest wall (at the junction of the chest and abdomen) to tighten the chest wall for 10 min at PEEP 7 cmH2O and 10 min without PEEP
| Study group | Role | What they receive |
|---|---|---|
| Infant < 6 months with severe bronchiolitis | Experimental | Infant will be recorded successively in 6 conditions (10 min each) :
* Without chest wall strapping at PEEP 0 and PEEP 7
* With chest wall strapping at PEEP 0 and PEEP 7
* again without chest wall strapping at PEEP 0 and PEEP 7. Receives: Other: Chest wall strapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophagal product time pressure
Average over 100 consecutive cycles of esophageal product time pressure value
Measured: 1 hour
Secondary outcomes (8)
Diaphragmatic product time pressure
Average over 100 consecutive cycles of diaphragmatic product time pressure value
Measured: 1 hour
Esophagal and diaphragmatic swing
Mean on 100 breaths of the amplitude (maximum value -minimum value) of the esophageal pressure (cmH2O) and gastric pressure (cmH2O)
Measured: 1 hour
Distribution of ventilation : center of ventilation
Mean over 1 minute of the center of the ventilation (%). Center of ventilation represents the average of the dorsal-ventral distribution of tidal variation using Electrical Impedance Tomography (values >50% indicating that the center of ventilation is located in the ventral part of the chest)
Measured: 1 hour
End expiratory lung volume
Average over 1 minute of the end expiratory lung impedance
Measured: 1 hour
Time ratio
average over 100 consecutive cycles of inspiratory to aspiratory time ratio
Measured: 1 hour
modified wood asthma score (mWCAS)
Value of the modified wood asthma score at the end of the recording period in each condition.
Minimal value 0 and maximal value 10. A score ≥ 3 mean a moderate-to-severe respiratory distress.
Measured: 1 hour
TcPCO2
Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute
Measured: 1 hour
EDIN scale (Newborn Pain and Discomfort Scale)
Value of the EDIN score at the end of the recording period in each condition. Minimal value 0 and maximal value 15. EDIN scores > 6 are considered expression of pain
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Why it stopped: As the epidemiology of bronchioles has changed over the last two winters with the introduction of beyfortus, we have few eligible patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Infant will be recorded successively in 6 conditions (10 min each) : * Without chest wall strapping at PEEP (Positive End Expiratory Pressure) 0 and PEEP 7 * With chest wall strapping at PEEP 0 and PEEP 7 * again without chest wall strapping at PEEP 0 and PEEP 7.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083077
- Sponsor's protocol ID
- 69HCL23_0821
- Acronym
- WRAPITIS
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study
- ClinicalTrials.gov ID
- NCT06083077
- Acronym / sponsor ID
- WRAPITIS / 69HCL23_0821
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Work of breathing, Non-invasive ventilation, Infant
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As the epidemiology of bronchioles has changed over the last two winters with the introduction of beyfortus, we have few eligible patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 13 Oct 2023 (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.
Bronchiolitis is the most common cause of admission to the Paediatric Intensive Care Unit (PICU) for respiratory distress.
The care of an infant with severe bronchiolitis is mainly based on symptomatic treatment (nutritional and respiratory support). The lower part of an infant's chest is larger than that of an older child, which can flatten the diaphragm, especially in obstructive disease with air trapping. Strapping the lower part (at the junction of the chest and abdomen) may provide a better condition for diaphragmatic contraction. Based on respiratory mechanics in infants and physiological studies in adults, investigators hypothesise that chest wall strapping may improve the ventilation and the diaphragmatic contraction.
Infant < 6 month with severe bronchiolitis admitted to the PICU will be recorded in 4 conditions with or without chest wall strapping and with a Continuous Positive Airway Pressure (CPAP) at 7 cmH2O or without CPAP. Physiological parameters (including work of breathing, respiratory parameters, distribution of ventilation) will be recorded and analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Infant will be recorded successively in 6 conditions (10 min each) : * Without chest wall strapping at PEEP (Positive End Expiratory Pressure) 0 and PEEP 7 * With chest wall strapping at PEEP 0 and PEEP 7 * again without chest wall strapping at PEEP 0 and PEEP 7.
| Arm | Type | Receives |
|---|---|---|
| Infant < 6 months with severe bronchiolitis | Experimental | Other: Chest wall strappingInfant will be recorded successively in 6 conditions (10 min each) : * Without chest wall strapping at PEEP 0 and PEEP 7 * With chest wall strapping at PEEP 0 and PEEP 7 * again without chest wall strapping at PEEP 0 and PEEP 7. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant < 6 months
- Admitted to the PICU for less than 48 hours
- With a diagnosis of bronchiolitis
- With a respiratory distress sign (mWCAS ≥ 3) and non-invasive ventilatory support
- With a naso or oro gastric tube for feeding
Key exclusion criteria (5 listed)
- Infants with severe bronchopulmonary disease, severe laryngomalacia, neuromuscular disease, bone disease, cyanotic heart disease
- Contraindication to the use of a gastric tube
- recent abdominal or thoracic surgery
- investigator able to perform physiological recording not available
- Patient who is not affiliated (or does not benefit from) to a national social security system
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 |
|---|---|---|
| Chest wall strappingAn elastic band (6 cm wide) is placed around the lower part of the chest wall (at the junction of the chest and abdomen) to tighten the chest wall for 10 min at PEEP 7 cmH2O and 10 min without PEEP | Other | Infant < 6 months with severe bronchiolitis |
Primary outcome
Esophagal product time pressure
Time frame: 1 hour
Average over 100 consecutive cycles of esophageal product time pressure value
8 secondary outcomes
Diaphragmatic product time pressure
Time frame: 1 hour
Esophagal and diaphragmatic swing
Time frame: 1 hour
Distribution of ventilation : center of ventilation
Time frame: 1 hour
End expiratory lung volume
Time frame: 1 hour
Time ratio
Time frame: 1 hour
modified wood asthma score (mWCAS)
Time frame: 1 hour
TcPCO2
Time frame: 1 hour
EDIN scale (Newborn Pain and Discomfort Scale)
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall strapping in people with Bronchiolitis, run by Hospices Civils de Lyon at 1 site 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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophagal product time pressure (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.