Chest and Abdominal Wall Strapping in Infant With Bronchiolitis

Bronchiolitis Clinical Trial

— WRAPITIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06083077
• Other study ID #: 69HCL23_0821
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Florent BAUDIN, Dr
• Phone: 04 72 12 97 35
• Email: florent.baudin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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

Locations

Country	Name	City	State
France	Réanimation pédiatrique	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophagal product time pressure	Average over 100 consecutive cycles of esophageal product time pressure value	1 hour
Secondary	Diaphragmatic product time pressure	Average over 100 consecutive cycles of diaphragmatic product time pressure value	1 hour
Secondary	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
Secondary	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
Secondary	End expiratory lung volume	Average over 1 minute of the end expiratory lung impedance	1 hour
Secondary	Time ratio	average over 100 consecutive cycles of inspiratory to aspiratory time ratio	1 hour
Secondary	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
Secondary	TcPCO2	Average of the transcutaneous CO2 (carbon dioxide) partial over 1 minute	1 hour
Secondary	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