Clinical trial NCT06379607: High Flow Nasal Cannula Rates in Pediatric Asthma
Official title: High Flow Nasal Cannula Rates in Pediatric Asthma Exacerbations: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pediatric Asthma
Keywords: Asthma
High Flow Nasal Cannula
Conventional Oxygen Therapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 27
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of participants enrolled
timeFrame: 12 months
Secondary outcomes:
measure: Mean Change in Pediatric Respiratory Assessment Measure (PRAM) Score
timeFrame: Baseline to 2 hours
measure: Mean Change in Respiratory Rate
timeFrame: Baseline to 2 hours
measure: Mean Total Duration of Continuous Albuterol
timeFrame: Approximately 3 days
measure: Percentage of Children with Escalation of Respiratory Support
timeFrame: 1 day
measure: Mean Total Duration of Respiratory Support
timeFrame: Until hospital discharge, approximately 5 days
measure: Percentage of Participants placed on Adjunct Asthma Therapies
timeFrame: Until hospital discharge, approximately 5 days
measure: Percentage of Participants who needed Sedation
timeFrame: Until hospital discharge, approximately 5 days
measure: Percentage of Participants on Antibiotics
timeFrame: Until hospital discharge, approximately 5 days
measure: Mean PICU Length of Stay (LOS)
timeFrame: Until hospital discharge, approximately 3 days
measure: Mean Hospital Length of Stay (LOS)
timeFrame: Until hospital discharge, approximately 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Golisano Children's Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: MicheleE E Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: