Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

NCT06083077 | Withdrawn

• 1 other identifier: 69HCL23_0821
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Esophagal product time pressure

  Average over 100 consecutive cycles of esophageal product time pressure value

  1 hour

Secondary Outcomes (8)

• Diaphragmatic product time pressure

  1 hour

• Esophagal and diaphragmatic swing

  1 hour

• Distribution of ventilation : center of ventilation

  1 hour

• End expiratory lung volume

  1 hour

• Time ratio

  1 hour

Study Arms (1)

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.

Other: Chest wall strapping

Interventions

Chest wall strapping OTHER

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

Infant < 6 months with severe bronchiolitis

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Réanimation pédiatrique

Bron, 69500, France

Location

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 13, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)