High Flow Nasal Cannula Rates in Pediatric Asthma
- Conditions
- Pediatric Asthma
- Interventions
- Device: "Low Flow" High Flow Nasal CannulaDevice: "High Flow" High Flow Nasal Cannula
- Registration Number
- NCT06379607
- Lead Sponsor
- University of Rochester
- Brief Summary
This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.
- Detailed Description
The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. Eligible patients will be admitted to the Pediatric Intensive Care Unit (PICU) after initial presentation to the emergency department (ED) or as a transfer from an outside hospital ED. Patients will be admitted to the PICU on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ED physician. Upon PICU admission, eligible patients will be consented, enrolled, and randomized into the study. All patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. Patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2L/min via standard facemark (control group), (2) high flow nasal cannula at 4L/min, and (3) high flow nasal cannula at 2L/kg/min (max 60L/min). Pediatric Respiratory Assessment Measure (PRAM) scores and vital signs will be taken at baseline and hourly for two hours. After the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. Patients will be followed longitudinally after study completion.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 27
- Age 2-17 years old with prior clinical diagnosis of asthma
- Admitted to PICU on standard asthma therapy defined as continuous albuterol and systemic corticosteroids
- Admitted to PICU on either COT or HFNC
- Admitted to PICU from either Golisano Children's Hospital ED or as a transport from an outside hospital ED within 6 hours of initial presentation
- PRAM score greater than or equal to 4 after completion of initial ED therapy
- Admitted to the PICU on NIV or invasive mechanical ventilation
- Admitted to the PICU from general floors or > 6 hours from initial presentation
- Presence of a tracheostomy or baseline NIV requirement
- Pregnancy
- Immunocompromised State
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Low Flow" High Flow Nasal Cannula at 4L/min "Low Flow" High Flow Nasal Cannula A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 4L/min and patient will be fitted with appropriately sized nasal prongs. "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min) "High Flow" High Flow Nasal Cannula A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 2L/kg/min (max 60L/min) and patient will be fitted with appropriately sized nasal prongs.
- Primary Outcome Measures
Name Time Method Percent of participants enrolled 12 months Percent of participants randomized divided by the percent of participants approached.
- Secondary Outcome Measures
Name Time Method Mean Total Duration of Respiratory Support Until hospital discharge, approximately 5 days Children will be followed longitudinally until hospital discharge and the total duration of hours patients spent on any respiratory support modality including COT, HFNC, noninvasive ventilation (NIV), invasive ventilation (IMV), or extracorporeal membrane oxygenation (ECMO) will be recorded.
Mean Change in Respiratory Rate Baseline to 2 hours The mean change in respiratory rate during the two our study period across all 3 study groups will be compared.
Mean PICU Length of Stay (LOS) Until hospital discharge, approximately 3 days Investigators will follow children longitudinally to record the amount of time children were admitted to the PICU for.
Percentage of Participants placed on Adjunct Asthma Therapies Until hospital discharge, approximately 5 days Investigators will describe how many children in each group were placed on adjunct asthma therapies including magnesium, heliox, leukotriene receptor antagonists, intravenous beta agonist therapies, and methylxantines either before, during, or after study period.
Percentage of Participants who needed Sedation Until hospital discharge, approximately 5 days Investigators will record how many children in each group required sedation and/or anxiolytics while on their respiratory support modality either during the trial or afterwards.
Mean Hospital Length of Stay (LOS) Until hospital discharge, approximately 7 days Investigators will follow children longitudinally to record the amount of time children were admitted to the hospital for.
Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score Baseline to 2 hours The Pediatric Respiratory Assessment Measure (PRAM) Score is a validated tool to measure asthma severity in pediatric patients. It is a scale that ranges from 0-12 with scores 4-7 indicating moderate asthma exacerbation and scores of 8-12 indicating severe exacerbation. The score has also been shown to be responsive to asthma therapies, with a decrease in score being indicative of improvement. PRAM scores will be measured at the start of the trial, at hour 1 and at the completion of the trial at hour 2. Mean changes in PRAM score will be compared across all three groups.
Mean Total Duration of Continuous Albuterol Approximately 3 days Children will be followed longitudinally until hospital discharge and record the total duration of hours patients spent on continuous albuterol.
Percentage of Children with Escalation of Respiratory Support 1 day The percentage of children requiring an increase in respiratory support (defined as escalation of support to HFNC of any flow rate, continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)) either during the 2-hour trial period, immediately upon completion, or within the first 24 hours of study enrollment time will be recorded.
Percentage of Participants on Antibiotics Until hospital discharge, approximately 5 days Investigators will record how many children completed full 5-7 day courses of antibiotics for bacterial pneumonia concurrent with their asthma exacerbation.
Trial Locations
- Locations (2)
University of Rochester Golisano Children's Hospital
🇺🇸Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States