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

Boston Children's Hospital

Status: Completed

Conditions: Bronchiolitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03492307

IRB-P00028533

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard Flow Protocol

Active Comparator group

Description:

Patients randomized to this arm will receive HFNC according to our current protocol with a maximum of 8L/min.

Treatment:

Other: Standard Flow for HFNC (Maximum 8L/minute)

Weight-Based Flow Protocol

Experimental group

Description:

Patients randomized to this arm will receive HFNC according to a weight-based algorithm at 2L/kg/min.

Treatment:

Other: Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)