Helmet Continuous Positive Airway Pressure Support for Severe Bronchiolitis in PICUs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02977585|
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : January 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Severe Bronchiolitis||Device: 10 cmH2O peep||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||488 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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)|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2020|
Active Comparator: group 1
high level support
Device: 10 cmH2O peep
positive end expiratory pressure
No Intervention: group 0
low level support
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977585