High Flow Nasal Cannula Rates in Pediatric Asthma

NCT ID: NCT06379607

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2026-09-30

Brief Summary

This is a randomized, open-label, 3-armed feasibility trial will examine conventional oxygen therapy (COT) vs high flow nasal cannula at 4L/min flow vs HFNC at 2L/kg/min flow (max 60L/min) in moderate to severe pediatric asthma exacerbations.

Detailed Description

The purpose of this feasibility trial is to examine the safety and efficacy of high flow nasal cannula in moderate to severe pediatric asthma exacerbations. Eligible patients will be admitted to the Pediatric Intensive Care Unit (PICU) after initial presentation to the emergency department (ED) or as a transfer from an outside hospital ED. Patients will be admitted to the PICU on standard asthma therapy (continuous albuterol and systemic corticosteroids) based on the discretion of the treating ED physician. Upon PICU admission, eligible patients will be consented, enrolled, and randomized into the study. All patients will be continued on standard asthma therapy of continuous albuterol at 20mg/hr and systemic intravenous corticosteroids. Patient will be randomized into one of three groups: (1) conventional oxygen therapy at 2L/min via standard facemark (control group), (2) high flow nasal cannula at 4L/min, and (3) high flow nasal cannula at 2L/kg/min (max 60L/min). Pediatric Respiratory Assessment Measure (PRAM) scores and vital signs will be taken at baseline and hourly for two hours. After the two-hour long study is completed, patients will be placed on a respiratory support modality as per the treating physician's discretion. Patients will be followed longitudinally after study completion.

Conditions

Pediatric Asthma

Study Design

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

Study Groups

Conventional Oxygen Therapy (COT)

Conventional Oxygen Therapy (COT) is the standard way to deliver oxygen to hypoxemic pediatric patients during an acute asthma exacerbation. Continuous albuterol will be administered via an aerogen set-up (aerogen mask, aerogen ultra, and a vibrating mesh nebulizer). Oxygen tubing will be connected to the wall and run at 2L/min as per the aerogen manufacturer's instructions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

"Low Flow" High Flow Nasal Cannula at 4L/min

A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 4L/min and patient will be fitted with appropriately sized nasal prongs.

Group Type: EXPERIMENTAL

"Low Flow" High Flow Nasal Cannula

Intervention Type: DEVICE

High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use lower flow rates.

"High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min)

A Fisher Paykl humidifier will be used for high flow humidification along with a flow meter and oxygen blender. A vibrating mesh nebulizer will be connected between the flow meter and the humidifier as per routine practice. Oxygen flow will be set to 2L/kg/min (max 60L/min) and patient will be fitted with appropriately sized nasal prongs.

Group Type: EXPERIMENTAL

"High Flow" High Flow Nasal Cannula

Intervention Type: DEVICE

High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use higher flow rates.

Interventions

"High Flow" High Flow Nasal Cannula

High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use higher flow rates.

Intervention Type: DEVICE

"Low Flow" High Flow Nasal Cannula

High Flow Nasal Cannula will be applied in both experimental groups but different flow rates will be used in each arm; this arm will use lower flow rates.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 2-17 years old with prior clinical diagnosis of asthma
• Admitted to PICU on standard asthma therapy defined as continuous albuterol and systemic corticosteroids
• Admitted to PICU on either COT or HFNC
• Admitted to PICU from either Golisano Children's Hospital ED or as a transport from an outside hospital ED within 6 hours of initial presentation
• PRAM score greater than or equal to 4 after completion of initial ED therapy

Exclusion Criteria

• Admitted to the PICU on NIV or invasive mechanical ventilation
• Admitted to the PICU from general floors or > 6 hours from initial presentation
• Presence of a tracheostomy or baseline NIV requirement
• Pregnancy
• Immunocompromised State

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Michele E. Smith

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MicheleE E Smith, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

University of Rochester Golisano Children's Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00009285

Identifier Type: -

Identifier Source: org_study_id