High Flow Nasal Cannula Rates in Pediatric Asthma

Pediatric Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06379607
• Other study ID #: HFNC2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: University of Rochester
• Contact: Michele E Smith, MD
• Phone: 5182296501
• Email: michele_smith[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 27
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pediatric Asthma

Intervention

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.
• "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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants enrolled	Percent of participants randomized divided by the percent of participants approached.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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