Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

Study Overview
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Brief Summary
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This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

Detailed Description
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This is a pilot study comparing a weight-based high-flow nasal cannula (HFNC) protocol with the current standard HFNC protocol for children <2yo admitted to South Shore Hospital with bronchiolitis. We currently use a flat limit of 8 liters of HFNC to support work of breathing and hypoxia in these patients. We will compare that to a weight-based protocol, which will provide 2L/kg/min of flow (flows generally between 6 and 20L/minute) to this patient population. The goal of this pilot study is to assess the feasibility of our study design. We will evaluate the functionality of a new weight-based flow protocol. We will also evaluate the functionality of a new bronchiolitis scoring tool, the Bronchiolitis Assessment Severity Score (BASS), and it's ability to guide care through the new protocol. We are also testing the feasibility of recruitment, randomization and retention. We are ultimately interested in whether a weight-based flow protocol reduces need for escalation to ICU-level care for children with moderate-severe bronchiolitis on HFNC.

Official Title
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Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial

Conditions
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Bronchiolitis

Intervention / Treatment
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* Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
* Other: Standard Flow for HFNC (Maximum 8L/minute)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: admission to inpatient pediatrics clinical diagnosis of bronchiolitis BASS score of moderate or severe Exclusion Criteria: non-english speakers patients with urgent need for CPAP, BIPAP or intubation

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Flow Protocol<br>Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min. | Other: Standard Flow for HFNC (Maximum 8L/minute)<br>* Maximum flow of 8L/minute.<br>|
| Experimental: Weight-Based Flow Protocol<br>Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min. | Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)<br>* A weight-based flow for HFNC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Need for escalation to NIV (CPAP or BIPAP) or intubation | During hospital admission | 
| Length of Stay | Length of hospital stay (admission to discharge or transfer) | During hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Flow Nasal Cannula