Clinical trial NCT06083077: Chest and Abdominal Wall Strapping in Infant With Bronchiolitis
Official title: Effect of Chest and Abdominal Wall Strapping on Ventilation and Work of Breathing in Infants With Severe Bronchiolitis: a Physiological Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
Work of breathing
Non-invasive ventilation
Infant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 23
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Esophagal product time pressure
timeFrame: 1 hour
Secondary outcomes:
measure: Diaphragmatic product time pressure
timeFrame: 1 hour
measure: Esophagal and diaphragmatic swing
timeFrame: 1 hour
measure: Distribution of ventilation : center of ventilation
timeFrame: 1 hour
measure: End expiratory lung volume
timeFrame: 1 hour
measure: Time ratio
timeFrame: 1 hour
measure: modified wood asthma score (mWCAS)
timeFrame: 1 hour
measure: TcPCO2
timeFrame: 1 hour
measure: EDIN scale (Newborn Pain and Discomfort Scale)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bron
country: France
facility: Réanimation pédiatrique
Study officials:
References: