High Flow Nasal Cannula Therapy (HFNC) Versus Nasal Positive Airway Pressure and or Nasal Positive Pressure Ventilation (NCPAP/ NPPV) in Infants With Severe Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The purpose of the study was to test the null hypothesis that there is no difference between
      nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV)
      and high flow nasal cannula (HFNC) devices when applied as a first non-invasive respiratory
      support mode for severe bronchiolitis
    

Detailed description: 
      The authors conducted a randomized controlled trial in the PICU of Children's hospital of
      Tunis. Participants aged from 7 days to 6 months, were eligible if all inclusion criteria
      were verified.

      On admission, demographic and clinical data were collected. When a participant met the
      inclusion criteria, respiratory support was randomly allocated as high flow nasal cannula
      (HFNC) or nasal continuous positive airway pressure / nasal positive pressure ventilation
      (CPAP/NPPV).

      Clinical parameters were monitored at treatment start and every 6 hours during the first 24
      hours and then twice daily thereafter.

      Participants in the HFNC group received heated and humidified gas flow with the Fisher &
      Paykel Healthcare HFNC system. The flow rate was usually started at the maximum flow rate for
      the size of cannula and a constant flow temperature of 37 °C.The flow rate will be
      progressively decreased when inspired fraction of oxygen (FiO2) was inferior to 30 percent
      (%).

      Participants in the CPAP/NPPV group received for first CPAP using a neonatal ventilator. The
      recommended starting pressure for CPAP was +6 centimeter of water (cmH2O). Positive
      continuous pressure could be increased to a maximum of +8 cmH2O. Optimal positive end
      expiratory pressure (PEEP) was what could maintain SpO2 at 94 per cent using the lowest
      fraction of inspired oxygen. PEEP will be decreased progressively of 1cmH2O every 6 hours
      from the optimal PEEP when FiO2 was inferior to 30% and there is no increased work of
      breathing.

      If CPAP failed to improve clinical respiratory distress, infant was allocated to NPPV
      strategy. Clinicians were not be authorized to change from CPAP to HFNC but if HFNC failed,
      they had to change HFNC to CPAP/NPPV strategy ventilation before intubation.

      Treatment failure criteria were urgent need to intubation or FiO2 superior to 60 % to
      maintain SpO2 ≥ 90% or increased work of breathing.

      Sample size (134 per group) was calculated on the basis of Type I error equal to 0,05, on
      statistical power equal to 0.95 on failure rate among controls estimated at 30% and assuming
      a minimum difference of failure rate to declare the superiority of intervention equal to 20%.
      A dropout rate equal to 20% was used for this calculation.

      Statistical Analysis Comparison of proportions was performed using Fisher exact test, and
      Student t test was used for comparison of means. For all analyses, significance level was
      defined as p < 0.05.

      All statistical analyses were performed using Microsoft Excel 365.
    

Intervention name(s): nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care