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

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute); Other: Standard Flow for HFNC (Maximum 8L/minute)

• Registration Number: NCT03492307
• Lead Sponsor: Boston Children's Hospital

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 Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-10
• Study Start: 2018-05-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight-Based Flow Protocol	Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)	Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.
Standard Flow Protocol	Standard Flow for HFNC (Maximum 8L/minute)	Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.

Primary Outcome Measures

Name	Time	Method
Treatment failure	During hospital admission	Need for escalation to NIV (CPAP or BIPAP) or intubation
Length of Stay	During hospital admission	Length of hospital stay (admission to discharge or transfer)

Trial Locations

Locations (1)

South Shore Hospital; 🇺🇸 Weymouth, Massachusetts, United States