High Flow Nasal Cannula Rates in Pediatric Asthma

High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: A Feasibility Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Pediatric Asthma
• Intervention / Treatment: Device: "Low Flow" High Flow Nasal Cannula; Device: "High Flow" High Flow Nasal Cannula

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester Golisano Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Oxygen Therapy (COT); Conventional 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.
Experimental: "Low Flow" High Flow Nasal Cannula at 4L/min; 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.	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.
Experimental: "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants enrolled	Percent of participants randomized divided by the percent of participants approached.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score	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.	Baseline to 2 hours
Mean Change in Respiratory Rate	The mean change in respiratory rate during the two our study period across all 3 study groups will be compared.	Baseline to 2 hours
Mean Total Duration of Continuous Albuterol	Children will be followed longitudinally until hospital discharge and record the total duration of hours patients spent on continuous albuterol.	Approximately 3 days
Percentage of Children with Escalation of Respiratory Support	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.	1 day
Mean Total Duration of Respiratory Support	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.	Until hospital discharge, approximately 5 days
Percentage of Participants placed on Adjunct Asthma Therapies	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.	Until hospital discharge, approximately 5 days
Percentage of Participants who needed Sedation	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.	Until hospital discharge, approximately 5 days
Percentage of Participants on Antibiotics	Investigators will record how many children completed full 5-7 day courses of antibiotics for bacterial pneumonia concurrent with their asthma exacerbation.	Until hospital discharge, approximately 5 days
Mean PICU Length of Stay (LOS)	Investigators will follow children longitudinally to record the amount of time children were admitted to the PICU for.	Until hospital discharge, approximately 3 days
Mean Hospital Length of Stay (LOS)	Investigators will follow children longitudinally to record the amount of time children were admitted to the hospital for.	Until hospital discharge, approximately 7 days

Collaborators and Investigators

• Sponsor: University of Rochester
• Investigators: Principal Investigator: MicheleE E Smith, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Asthma; High Flow Nasal Cannula; Conventional Oxygen Therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00009285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No