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Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis (BRONCHIO-DV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT02602678
First received: November 9, 2015
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Severe Bronchiolitis Procedure: Supine then Prone position Procedure: Prone then supine position

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: November 2015
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRONE-Supine
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).
Procedure: Prone then supine position
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)
Experimental: SUPINE - Prone
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).
Procedure: Supine then Prone position
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)

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02602678

Locations
France
Hospices Civils de Lyon
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02602678     History of Changes
Other Study ID Numbers: 69HCL15_0430
Study First Received: November 9, 2015
Last Updated: January 27, 2016

Keywords provided by Hospices Civils de Lyon:
Children.
prone position
acute viral bronchiolitis
syncytial virus
work of breathing
intrinsic PEEP

Additional relevant MeSH terms:
Respiratory Aspiration
Bronchiolitis
Bronchiolitis, Viral
Positive-Pressure Respiration, Intrinsic
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Bronchitis
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Respiratory Insufficiency

ClinicalTrials.gov processed this record on June 23, 2017