Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs
Binary randomized peep level of Helmet CPAP (1-0). The first patient enrolled will be assign to treatment 1 (10 cmH2O peep level), independently from its BSS. The following patients enrolled will be assign to treatment 0 (5 cmH2O peep level), and consecutively up to 25 patients at least.
- 10 cmH2O peep, 50 L/min gas flow, fraction of inspired oxygen (FiO2) 0.5 on PICU admission (random 1)
- 5 cmH2O peep, 50 L/min gas flow, FiO2 0.5 on PICU admission (random 0) If clinical and respiratory worsening, reduction of pH or partial oxygen arterial pressure (PaO2)/FiO2 occurs in the following first hour after Helmet CPAP treatment start, patients enrolled will receive endotracheal intubation, full face mask non invasive ventilation or higher peep level treatment (7.5-10 cmH2O) according to clinical evaluation, if necessary.
In investigator's experience, early worsening of severe bronchiolitis in PICU in the first hour of Helmet CPAP treatment with 10 cmH2O peep level leads to endotracheal intubation.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Helmet Continous Positive Airway Pressure (CPAP) Management and Positive End Expiratory Pressure (PEEP) Level Impact on Severe Bronchiolitis Admitted in Pediatric Intensive Care Units (PICUs)|
- incidence of intubation following Helmet CPAP treatment [ Time Frame: 7 days ]to evaluate intubation rate on severe bronchiolitis admitted in PICU and supported with Helmet CPAP non invasive ventilation with 10 peep level in group 1, and 5 peep level in group 0.
- incidence of pneumothorax following Helmet CPAP treatment [ Time Frame: 72 hours ]pneumothorax occurrence
- length of stay [ Time Frame: days 30 ]length of PICU stay
|Study Start Date:||November 2016|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Active Comparator: group 1
high level support
Device: 10 cmH2O peep
positive end expiratory pressure
No Intervention: group 0
low level support
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT02977585
|Bambino Gesù Children's Hospital||Recruiting|
|Rome, Lazio, Italy, 00100|
|Contact: emanuele rossetti, md 3478370026 ext 0039 email@example.com|
|Contact 3478370026 ext 0039 firstname.lastname@example.org|
|Principal Investigator: emanuele rossetti, md|