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

NCT ID: NCT03492307

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2020-03-30

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Flow Protocol

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

Group Type: ACTIVE_COMPARATOR

Standard Flow for HFNC (Maximum 8L/minute)

Intervention Type: OTHER

Maximum flow of 8L/minute.

Weight-Based Flow Protocol

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

A weight-based flow for HFNC.

Interventions

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

A weight-based flow for HFNC.

Intervention Type: OTHER

Standard Flow for HFNC (Maximum 8L/minute)

Maximum flow of 8L/minute.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Shore Hospital

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alla Smith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alla Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

South Shore Hospital

Weymouth, Massachusetts, United States

Countries

United States

References

Smith A, Banville D, O'Rourke C, Melvin P, Batey L, Borgmann A, Waltzman M, Agus MSD. Randomized Trial of Weight-Based Versus Fixed Limit High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2023 May 1;13(5):387-393. doi: 10.1542/hpeds.2022-006656.

Reference Type: DERIVED

PMID: 37122050 (View on PubMed)

Other Identifiers

IRB-P00028533

Identifier Type: -

Identifier Source: org_study_id