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NCT Number: NCT02602678

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

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.

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Key information

Conditions

Severe Bronchiolitis Bronchial Diseases Bronchiolitis Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Positive-Pressure Respiration, Intrinsic Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supine then Prone position

Procedure

One hour in supine position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash-out) and one hour in prone position with CPAP (+7 cmH2O)

Prone then supine position

Procedure

One hour in prone position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash out ) and one hour in supine position with CPAP (+7 cmH2O)

Primary outcomes

  1. Work of breathing

    Time frame: 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 outcomes

  1. Intrinsic PEEP

    Time frame: 60 min

    Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation

  2. Inspiratory:Expiratory Time Ratio

    Time frame: 60 min

    Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio

  3. Heart rate

    Time frame: 60 min

    Evolution of the clinical and oxygenation parameter within the first hour in each position.

  4. Respiratory rate

    Time frame: 60 min

    Evolution of the clinical and oxygenation parameters within the first hour in each position.

  5. SPO2

    Time frame: 60 min

    Evolution of the clinical and oxygenation parameters within the first hour in each position.

  6. Transcutaneous CO2

    Time frame: 60 min

    Evolution of the clinical and oxygenation parameters within the first hour in each position.

  7. EDIN score (neonatal pain and discomfort scale)

    Time frame: 60 min

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: BRONCHIO-DV

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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