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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Intrinsic PEEP [ Time Frame: 60 min ]
    Mean on 10 breaths of the intrinsic positive end expiratory pressure in spontaneous ventilation
  • Inspiratory:Expiratory Time Ratio [ Time Frame: 60 min ]
    Mean on 100 breaths of the Inspiratory:Expiratory Time Ratio
  • Heart rate [ Time Frame: 60 min ]
    Evolution of the clinical and oxygenation parameter within the first hour in each position.
  • Respiratory rate [ Time Frame: 60 min ]
    Evolution of the clinical and oxygenation parameters within the first hour in each position.
  • SPO2 [ Time Frame: 60 min ]
    Evolution of the clinical and oxygenation parameters within the first hour in each position.
  • Transcutaneous CO2 [ Time Frame: 60 min ]
    Evolution of the clinical and oxygenation parameters within the first hour in each position.
  • Comfort [ Time Frame: 60 min ]
    EDIN score


Information By: Hospices Civils de Lyon

Dates:
Date Received: November 9, 2015
Date Started: November 2015
Date Completion:
Last Updated: January 27, 2016
Last Verified: January 2016