High Flow Nasal Cannula for Childhood Asthma

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to deliver oxygen to children with moderate to severe asthma attacks. Researchers compare conventional oxygen therapy (the usual method) with two different settings of high flow nasal cannula, a specialized oxygen delivery method. The trial seeks children aged 2-17 diagnosed with asthma and currently in the pediatric intensive care unit receiving specific asthma treatments. Participants must have been admitted to the hospital within 6 hours of their asthma symptoms worsening. As an unphased trial, this study offers a unique opportunity to contribute to improving asthma care for children.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a high flow nasal cannula (HFNC) in children with asthma is generally safe. Studies have found that children with severe asthma usually tolerate HFNC well and often find it more comfortable than other oxygen delivery methods, such as an aerosol mask.

Although HFNC is safe, it might delay other necessary treatments. Overall, HFNC remains a practical and safe option for managing asthma in children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about high flow nasal cannula (HFNC) treatments for childhood asthma because they offer a unique approach compared to conventional oxygen therapy. The "High Flow" HFNC delivers oxygen at 2L/kg/min, providing high levels of humidified oxygen, which can potentially offer better respiratory support during severe asthma attacks. In contrast, the "Low Flow" HFNC provides a more moderate flow at 4L/min, which could be a less intense but still effective alternative. Both methods use a vibrating mesh nebulizer, which enhances medication delivery directly to the lungs. These features could make HFNC more effective in reducing breathing difficulties quickly, compared to traditional oxygen therapy which typically involves a lower flow rate and less targeted delivery.

What evidence suggests that this trial's treatments could be effective for childhood asthma?

This trial will compare different oxygen delivery methods for children with asthma. Research has shown that a high flow nasal cannula (HFNC) can help children breathe easier during severe attacks. In this trial, one group will receive "High Flow" HFNC at 2L/kg/min (max 60L/min), while another group will receive "Low Flow" HFNC at 4L/min. Studies have found that children using HFNC experienced a noticeable drop in their breathing rate within 24 hours, from about 40 breaths per minute to around 31, indicating more comfortable breathing. Another study found that HFNC was linked to less shortness of breath compared to regular oxygen therapy, the standard treatment in the control group. While HFNC is generally safe and effective, careful use is important to ensure other necessary treatments are not delayed. ^{1 2 5 6 7}

Who Is on the Research Team?

MicheleE E Smith, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39212235/

A matched analysis of the use of high flow nasal cannula for ... Conclusions: Encounters using HFNC for severe acute pediatric asthma had decreased clinical improvement in 24 h of hospitalization compared to ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.27233

A matched analysis of the use of high flow nasal cannula ... Encounters using HFNC for severe acute pediatric asthma had decreased clinical improvement in 24 h of hospitalization compared to matched ...

3. vapotherm.com vapotherm.com/blog/growing-evidence-suggests-high-flow-nasal-cannula-is-safe-and-effective-tool-for-children-with-asthma-presenting-in-the-emergency-department/

Growing Evidence Suggests High Flow Nasal Cannula Is ... As for respiratory rate, the results show a decrease from hour 0 (40 ± 13 per min, p < 0.01) to hour 24 (31 ± 8/min, p < 0.01) in the children treated with HFNC ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837591/

The efficacy of high-flow oxygen versus conventional oxygen ... Our meta-analysis included four RCTs and 175 patients, and the results revealed that high-flow oxygen therapy was associated with a significantly lower dyspnoea ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526054221000038

Review High-flow nasal cannula in children with asthma ... The use of HFNC in children with asthma exacerbations is generally feasible and safe. •. Practitioners should be cautious of the risk of delaying escalation ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ppul.26606

Outcomes of a respiratory therapist driven high flow nasal ... HFNC has been shown to be safe in patients with critical asthma, and the nasal cannula may be more comfortable compared to an aerosol mask, ...

7. publications.aap.org publications.aap.org/hospitalpediatrics/article/15/3/195/201001/Improving-Length-of-Stay-by-Reducing-High-Flow

Improving Length of Stay by Reducing High-Flow Nasal ... We aimed to reduce HFNC length of treatment (LOT) and length of stay (LOS) by 10% for patients aged 1 month to 5 years with bronchiolitis, pneumonia, or asthma ...