Trials / Withdrawn
WithdrawnNCT06379607
High Flow Nasal Cannula Rates in Pediatric Asthma
High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: A Feasibility Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | "High Flow" High Flow Nasal Cannula | 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. |
| DEVICE | "Low Flow" High Flow Nasal Cannula | 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. |
Timeline
- Start date
- 2025-01-15
- Primary completion
- 2026-01-15
- Completion
- 2026-09-30
- First posted
- 2024-04-23
- Last updated
- 2026-03-27
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06379607. Inclusion in this directory is not an endorsement.