High Flow Nasal Cannula for Childhood Asthma

Recruiting at 1 trial location

Overseen By Michele E Smith, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Albuterol, Corticosteroids

Disqualifiers: NIV, Tracheostomy, Pregnancy, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

27 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment High Flow Nasal Cannula for childhood asthma?

Research shows that high flow nasal cannula (HFNC) therapy is used in pediatric wards for children with asthma exacerbations, suggesting it may help improve breathing in these cases. Additionally, HFNC is commonly used in pediatric intensive care for children with breathing difficulties, indicating its potential effectiveness in managing respiratory distress. ^{1 2 3 4 5}

Is high flow nasal cannula therapy safe for children?

High flow nasal cannula (HFNC) therapy is increasingly used in children, especially in intensive care settings, and studies suggest it is generally well tolerated and safe for infants and children with moderate to severe respiratory issues. ^{1 5 6 7 8}

How does the High Flow Nasal Cannula treatment differ from other treatments for childhood asthma?

High Flow Nasal Cannula (HFNC) treatment is unique because it delivers oxygen at a high flow rate through a nasal tube, which can help children with asthma breathe more easily during moderate respiratory failure. Unlike traditional oxygen therapy, HFNC provides a consistent flow of warm, humidified air, which can be more comfortable and effective in emergency situations. ^{9 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

MicheleE E Smith, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for children aged 3-17 with a clinical diagnosis of asthma, who are admitted to the PICU on standard asthma treatments and require oxygen therapy. They must have had an exacerbation severe enough to score at least 8 on the PASS after initial emergency treatment.

Inclusion Criteria

I am in the pediatric intensive care unit on oxygen therapy.

I am in the PICU for asthma, receiving albuterol and steroids.

I was admitted to the PICU within 6 hours from the ER.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive randomized oxygen therapy (COT or HFNC) and are monitored for 2 hours in the PICU

2 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment until hospital discharge

Approximately 5-7 days

Daily monitoring

Treatment Details

Interventions

• High Flow Nasal Cannula

Trial Overview The study compares conventional oxygen therapy (COT) against two different flow rates of High Flow Nasal Cannula (HFNC): one at a 'high flow' rate of 4L/min and another based on weight ('low flow') up to a maximum of 60L/min in treating moderate to severe pediatric asthma.

Participant Groups

Group I: "Low Flow" High Flow Nasal Cannula at 4L/min Experimental Treatment 1 Intervention

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 II: "High Flow" High Flow Nasal Cannula at 2L/kg/min (max 60L/min) Experimental Treatment 1 Intervention

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 III: Conventional Oxygen Therapy (COT) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

References

1. Australia pubmed.ncbi.nlm.nih.gov

A case series of paediatric high flow nasal cannula therapy. [2013]

2. Spain pubmed.ncbi.nlm.nih.gov

[Treatment with high-flow oxygen therapy in asthma exacerbations in a paediatric hospital ward: Experience from 2012 to 2016]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula Use Outside of the ICU Setting. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula use in pediatric patients for other indications than acute bronchiolitis-a scoping review of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The Relationship between High Flow Nasal Cannula Flow Rate and Effort of Breathing in Children. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

High flow nasal cannula use outside of the ICU; factors associated with failure. [2018]

7. Australia pubmed.ncbi.nlm.nih.gov

Velocity-based target flow rate for high-flow nasal cannula oxygen therapy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cardiopulmonary outcomes following high flow nasal cannula in pediatric population: A systematic review. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Pilot Clinical Trial of High-Flow Oxygen Therapy in Children with Asthma in the Emergency Service. [2019]

10. Spain pubmed.ncbi.nlm.nih.gov

[Sputum induction in children: Technical development]. [2010]

11. England pubmed.ncbi.nlm.nih.gov

Are we recording peak flows properly in young children? [2013]

12. Mexico pubmed.ncbi.nlm.nih.gov

[Knowledge of flowmetry among asthmatic children and adolescents]. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Measurement of exhaled nitric oxide in children, 2001. [2022]