Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

Not Applicable

Not yet recruiting

• Conditions: Bronchiolitis
• Interventions: Other: Chest wall strapping

• Registration Number: NCT06083077
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted QC: 2023-10-12
• Last Update Submitted: 2023-10-12
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infant < 6 months with severe bronchiolitis	Chest wall strapping	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.

Primary Outcome Measures

Name	Time	Method
Esophagal product time pressure	1 hour	Average over 100 consecutive cycles of esophageal product time pressure value

Secondary Outcome Measures

Name	Time	Method
End expiratory lung volume	1 hour	Average over 1 minute of the end expiratory lung impedance
TcPCO2	1 hour	Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute
Diaphragmatic product time pressure	1 hour	Average over 100 consecutive cycles of diaphragmatic product time pressure value
Esophagal and diaphragmatic swing	1 hour	Mean on 100 breaths of the amplitude (maximum value -minimum value) of the esophageal pressure (cmH2O) and gastric pressure (cmH2O)
Distribution of ventilation : center of ventilation	1 hour	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)
Time ratio	1 hour	average over 100 consecutive cycles of inspiratory to aspiratory time ratio
EDIN scale (Newborn Pain and Discomfort Scale)	1 hour	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
modified wood asthma score (mWCAS)	1 hour	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.

Trial Locations

Locations (1)

Réanimation pédiatrique; 🇫🇷 Bron, France