Chest and Abdominal Wall Strapping in Infant With Bronchiolitis (WRAPITIS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Bronchiolitis
• Intervention / Treatment: Other: Chest wall strapping

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Réanimation pédiatrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infant < 6 months with severe bronchiolitis; 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.	Other: Chest 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophagal product time pressure	Average over 100 consecutive cycles of esophageal product time pressure value	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic product time pressure	Average over 100 consecutive cycles of diaphragmatic product time pressure value	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)	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)	1 hour
End expiratory lung volume	Average over 1 minute of the end expiratory lung impedance	1 hour
Time ratio	average over 100 consecutive cycles of inspiratory to aspiratory time ratio	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.	1 hour
TcPCO2	Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute	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	1 hour

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Infant; Non-invasive ventilation; Bronchiolitis; Work of breathing
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 69HCL23_0821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No