Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

Not Applicable

Completed

• Conditions: Severe Bronchiolitis
• Interventions: Procedure: Supine then Prone position; Procedure: Prone then supine position

• Registration Number: NCT02602678
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-10
• Study First Posted: 2015-11-11
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SUPINE - Prone	Supine then Prone position	We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).
PRONE-Supine	Prone then supine position	We test the hypothesis that in infants with severe bronchiolitis, prone position reduces the work of breathing (WOB) and the intrinsic Positive End Expiratory Pressure (PEEP).

Primary Outcome Measures

Name	Time	Method
Work of breathing	60 min	The primary outcome is the work of breathing (WOB) estimated by the mean on 100 breaths of the esophageal and trans-diaphragmatic Pressure-Time Product (PTP) at the end of the first hour.

Secondary Outcome Measures

Name	Time	Method
Transcutaneous CO2	60 min	Evolution of the clinical and oxygenation parameters within the first hour in each position.
Heart rate	60 min	Evolution of the clinical and oxygenation parameter within the first hour in each position.
EDIN score (neonatal pain and discomfort scale)	60 min
SPO2	60 min	Evolution of the clinical and oxygenation parameters within the first hour in each position.
Intrinsic PEEP	60 min	Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation
Respiratory rate	60 min	Evolution of the clinical and oxygenation parameters within the first hour in each position.
Inspiratory:Expiratory Time Ratio	60 min	Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France