Weight-based Flow Rates for Children With Bronchiolitis on High-Flow Nasal Cannula: A Pilot Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Treatment failure
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 2 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Standard Flow Protocol
Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.
Intervention: Standard Flow for HFNC (Maximum 8L/minute) (Other)
Weight-Based Flow Protocol
Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.
Intervention: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute) (Other)
Outcomes
Primary Outcomes
Treatment failure
Time Frame: During hospital admission
Need for escalation to NIV (CPAP or BIPAP) or intubation
Length of Stay
Time Frame: During hospital admission
Length of hospital stay (admission to discharge or transfer)
Secondary Outcomes
No secondary outcomes reported
Investigators
Alla Smith
Principal Investigator
Boston Children's Hospital