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Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06083077
Acronym
WRAPITIS
Enrollment
0
Registered
2023-10-13
Start date
2023-10-31
Completion date
2025-11-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Keywords

Bronchiolitis, Work of breathing, Non-invasive ventilation, Infant

Brief 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). 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.

Interventions

OTHERChest wall strapping

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Esophagal product time pressure1 hourAverage over 100 consecutive cycles of esophageal product time pressure value

Secondary

MeasureTime frameDescription
Esophagal and diaphragmatic swing1 hourMean on 100 breaths of the amplitude (maximum value -minimum value) of the esophageal pressure (cmH2O) and gastric pressure (cmH2O)
Distribution of ventilation : center of ventilation1 hourMean 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)
End expiratory lung volume1 hourAverage over 1 minute of the end expiratory lung impedance
Diaphragmatic product time pressure1 hourAverage over 100 consecutive cycles of diaphragmatic product time pressure value
modified wood asthma score (mWCAS)1 hourValue 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.
TcPCO21 hourAverage of the transcutaneous CO2 (carbon dioxide) partial over 1 minute
EDIN scale (Newborn Pain and Discomfort Scale)1 hourValue 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
Time ratio1 houraverage over 100 consecutive cycles of inspiratory to aspiratory time ratio

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026