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

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03492307
• Other study ID #: IRB-P00028533
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Other:
• Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)
A weight-based flow for HFNC.
• Standard Flow for HFNC (Maximum 8L/minute)
Maximum flow of 8L/minute.

Locations

Country	Name	City	State
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	South Shore Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure	Need for escalation to NIV (CPAP or BIPAP) or intubation	During hospital admission
Primary	Length of Stay	Length of hospital stay (admission to discharge or transfer)	During hospital admission