Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

NCT ID: NCT06083077

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Chest wall strapping

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Réanimation pédiatrique

Bron, , France

Countries

France

Other Identifiers

69HCL23_0821

Identifier Type: -

Identifier Source: org_study_id