Clinical trial NCT02602678: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
Official title: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Bronchiolitis
Keywords: Children.
prone position
acute viral bronchiolitis
syncytial virus
work of breathing
intrinsic PEEP
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 16
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.


Eligibility criteria: Inclusion Criteria:

* Infant \< 6 months
* Admitted in the pediatric intensive care unit of the Femme-Mère-Enfant hospital, Hospices Civils de Lyon, France
* With severe acute viral bronchiolitis requiring ventilatory support (mWCAS \> 4 and/or and or FiO2\> 40% and/or hypercapnic acidosis (pH\<7.30 and/or pCO2\>8 kPa))
* Signed informed consent by the two parents or the owner of parental authority

Exclusion Criteria:

* Chronic respiratory, neuromuscular, ENT or cardiac disease
* Contraindication for placement of esophageal probe (esophageal surgery, varices, ...)
* Children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, ...)
* Children not affiliated to a social security scheme

Primary outcomes:
measure: Work of breathing
timeFrame: 60 min
Secondary outcomes:
measure: Intrinsic PEEP
timeFrame: 60 min
measure: Inspiratory:Expiratory Time Ratio
timeFrame: 60 min
measure: Heart rate
timeFrame: 60 min
measure: Respiratory rate
timeFrame: 60 min
measure: SPO2
timeFrame: 60 min
measure: Transcutaneous CO2
timeFrame: 60 min
measure: EDIN score (neonatal pain and discomfort scale)
timeFrame: 60 min
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
citation: Baudin F, Emeriaud G, Essouri S, Beck J, Portefaix A, Javouhey E, Guerin C. Physiological Effect of Prone Position in Children with Severe Bronchiolitis: A Randomized Cross-Over Study (BRONCHIO-DV). J Pediatr. 2019 Feb;205:112-119.e4. doi: 10.1016/j.jpeds.2018.09.066. Epub 2018 Nov 14.