Study Stopped
No longer performing study due to lack of funding and protected research time by PI
High Flow Nasal Cannula Rates in Pediatric Asthma
1 other identifier
interventional
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2024
CompletedFirst Posted
Study publicly available on registry
April 23, 2024
CompletedStudy Start
First participant enrolled
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedMarch 27, 2026
March 1, 2026
1 year
April 10, 2024
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of participants enrolled
Percent of participants randomized divided by the percent of participants approached.
12 months
Secondary Outcomes (10)
Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score
Baseline to 2 hours
Mean Change in Respiratory Rate
Baseline to 2 hours
Mean Total Duration of Continuous Albuterol
Approximately 3 days
Percentage of Children with Escalation of Respiratory Support
1 day
Mean Total Duration of Respiratory Support
Until hospital discharge, approximately 5 days
- +5 more secondary outcomes
Study Arms (3)
Conventional Oxygen Therapy (COT)
NO INTERVENTIONConventional Oxygen Therapy (COT) is the standard way to deliver oxygen to hypoxemic pediatric patients during an acute asthma exacerbation. Continuous albuterol will be administered via an aerogen set-up (aerogen mask, aerogen ultra, and a vibrating mesh nebulizer). Oxygen tubing will be connected to the wall and run at 2L/min as per the aerogen manufacturer's instructions.
"Low Flow" High Flow Nasal Cannula at 4L/min
EXPERIMENTALA 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)
EXPERIMENTALA 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.
Interventions
High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use higher flow rates.
High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use lower flow rates.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Rochester Golisano Children's Hospital
Rochester, New York, 14642, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
MicheleE E Smith, MD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
April 10, 2024
First Posted
April 23, 2024
Study Start
January 15, 2025
Primary Completion
January 15, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share