Nasal High Flow for COPD

Overseen By Saramaria Afanador Castiblanco, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Bedrest, Hemodynamic instability, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Nasal High Flow for COPD?

Research suggests that high-flow nasal cannula (HFNC) can improve breathing function in patients with COPD, especially during acute flare-ups. However, its impact on overall clinical outcomes, like reducing the need for more invasive breathing support, is still uncertain. ^{1 2 3 4 5}

Is high-flow nasal cannula therapy safe for humans?

High-flow nasal cannula (HFNC) therapy is generally considered safe for humans, with studies showing it provides better or comparable oxygenation compared to traditional methods. Some side effects like nosebleeds, nasal discomfort, and dryness have been reported, but no unexpected side effects were found in the reviewed studies. ^{2 3 6 7 8}

How is the nasal high flow treatment different from other treatments for COPD?

Nasal high flow (NHF) treatment is unique because it delivers a heated and humidified air-oxygen mixture through a nasal cannula at high flow rates, which can help improve breathing in COPD patients. Unlike traditional oxygen therapy, NHF can provide a more comfortable and effective way to support ventilation, especially during acute exacerbations. ^{1 4 5 7 9}

What is the purpose of this trial?

This study aims to assess whether to describe the effects of the administration of nasal high flow (NHF) at 70 liters per minute (L/min) in a 6-Minute Walk Test (6-MWT) among Chronic Obstructive Pulmonary Disease (COPD) patients and to characterize the association between self-reported dyspnea with and without NHF at 70 L/min following a 6-MWT.

Research Team

Saramaria Afanador Castiblanco, M.D.

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with Chronic Obstructive Pulmonary Disease (COPD) who are able to perform a 6-Minute Walk Test (6-MWT). Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

Able to consent

I use a low-flow nasal cannula at 4L/min or less, or I don't use supplemental oxygen.

I can walk on my own without help.

Exclusion Criteria

I am currently on bedrest.

I am unable to understand or follow the study's requirements.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a cross-over study with Nasal High Flow and Low Flow Cannula treatments, each for 30 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nasal High Flow

Trial Overview The study is testing the effects of two types of oxygen delivery during exercise: high flow nasal cannula at 70 liters per minute and low flow. It measures how these affect exercise tolerance and breathlessness in COPD patients after walking for six minutes.

Participant Groups

Group I: Nasal High Flow Cannula Experimental Treatment 2 Interventions

Nasal High Flow cannula at 70 liters per minute for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to Nasal Low Flow Cannula at less than or equal to 4 liters per minute with supplemental oxygen for 30 minutes

Group II: Nasal Low Flow Cannula Active Control 2 Interventions

Low Flow Nasal Cannula at less than or equal to 4 liters per minute with supplemental oxygen at patient's baseline for 30 minutes. Given that this is a cross-over study, participants on this arm will be then crossed over to High Flow Cannula at 70 liters per minute for 30 minutes

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

American Thoracic Society

Collaborator

Trials

12

Recruited

690+

Findings from Research

In a study of 337 patients with acute COPD exacerbation, high-flow nasal cannula (HFNC) did not significantly reduce the need for intubation compared to conventional oxygen therapy, indicating similar efficacy in this regard.

HFNC was associated with a longer hospital stay and higher costs compared to conventional oxygen therapy, suggesting that while it may not improve clinical outcomes, it could lead to increased resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. Xia, J., Gu, S., Lei, W., et al.[2022]

Humidified high-flow nasal cannula oxygen therapy (HFNC) significantly improves respiratory function in stable COPD patients, as evidenced by higher FEV1, FEV1%, and FEV1/FVC values compared to conventional oxygen therapy (COT).

HFNC also enhances the quality of life and reduces adverse reactions in patients, with better blood gas analysis results (higher pH and PaO2, lower PaCO2) and improved exercise capacity, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of humidified high-flow nasal cannula oxygen therapy on respiratory function recovery in stable COPD patients. Lyu, R., Wang, W., Wang, W., et al.[2022]

High-flow nasal cannula (HFNC) therapy significantly reduces carbon dioxide levels (PaCO2) and length of hospital stay in patients with COPD and type II respiratory failure compared to noninvasive ventilation (NIV), based on a meta-analysis of 6 randomized controlled trials involving 525 patients.

HFNC therapy also has a lower incidence of nasal facial skin breakdown compared to NIV, indicating it may be a safer option for patients, with no significant differences in other critical outcomes like oxygen levels, need for intubation, or mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of high-flow nasal cannula therapy in patients with COPD and type II respiratory failure: a meta-analysis and systematic review. Xu, Z., Zhu, L., Zhan, J., et al.[2022]

High-flow nasal cannula (HFNC) therapy does not significantly reduce the need for intubation or reintubation compared to noninvasive ventilation (NIV) in patients with COPD, but it is associated with lower skin breakdown and higher comfort levels.

HFNC therapy shows a lower risk of treatment failure compared to conventional oxygen therapy (COT) during initial treatment for COPD exacerbations, and it also improves quality of life compared to long-term oxygen therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of high-flow nasal cannula in patients with chronic obstructive pulmonary disease under exacerbation and stable phases: A systematic review and meta-analysis. Yang, H., Huang, D., Luo, J., et al.[2023]

High-flow nasal cannula (HFNC) therapy significantly improved dyspnea, breathing frequency, and oxygen saturation in 90 out of 111 patients treated outside the ICU, indicating its efficacy in non-ICU settings.

Despite the benefits observed, the study reported a high overall mortality rate of 50%, suggesting that HFNC may often be used in a palliative context, particularly among patients with do not resuscitate (DNR) orders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of High-Flow Nasal Cannula Oxygen Outside the ICU. Zemach, S., Helviz, Y., Shitrit, M., et al.[2020]

High flow nasal cannula (HFNC) is an effective and safe treatment for adults with acute hypercapnic respiratory failure (AHRF), showing comparable outcomes in intubation rates, mortality, and arterial blood gas improvement when compared to conventional oxygen treatment (COT) and non-invasive ventilation (NIV).

HFNC offers greater comfort and fewer adverse events than NIV, and it can significantly reduce heart rate, respiratory rate, and hospital stay length, while also decreasing the need for NIV in patients with compensated hypercapnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of High Flow Nasal Therapy with Non-Invasive Ventilation and Conventional Oxygen Therapy for Acute Hypercapnic Respiratory Failure: A Meta-Analysis of Randomized Controlled Trials. Xu, C., Yang, F., Wang, Q., et al.[2023]

High-Flow Nasal Cannula (HFNC) therapy offers several physiological benefits for COPD patients, including improved gas exchange, enhanced comfort, and a more stable oxygen delivery compared to conventional oxygen therapy.

In stable COPD patients, HFNC has been shown to improve quality of life and reduce dyspnea, while in exacerbated cases, it may serve as a viable alternative to non-invasive ventilation and conventional oxygen therapy, although more research is needed to confirm its superiority.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Flow Through Nasal Cannula in Stable and Exacerbated Chronic Obstructive Pulmonary Disease Patients. Bruni, A., Garofalo, E., Cammarota, G., et al.[2020]

High-flow nasal cannula oxygen (HFNC) has been shown to improve oxygenation in adults with severe respiratory diseases, demonstrating better or comparable results compared to traditional face masks and nasal cannulas in a review of 15 studies involving 943 patients.

HFNC is associated with minimal side effects, such as nasal discomfort and dryness, and may reduce the need for more invasive treatments like positive pressure ventilation, indicating its potential as a safer alternative for managing hypoxemic respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen in adult patients: a narrative review. Sotello, D., Rivas, M., Mulkey, Z., et al.[2022]

A study of 321 Japanese adults using high-flow nasal cannula (HFNC) oxygen therapy showed significant improvements in respiratory parameters, including oxygen levels and respiratory rate, indicating its efficacy in treating acute hypoxemic respiratory failure and other conditions.

HFNC was primarily used in intensive care and general wards, with a median duration of 4 days, and about two-thirds of patients survived to discharge, highlighting its potential effectiveness in real-world clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical practice of high-flow nasal cannula oxygen therapy in adults: A Japanese cross-sectional multicenter survey. Ito, J., Nagata, K., Sato, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula versus conventional oxygen therapy in acute COPD exacerbation with mild hypercapnia: a multicenter randomized controlled trial. [2022]

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

Effect of humidified high-flow nasal cannula oxygen therapy on respiratory function recovery in stable COPD patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The efficacy and safety of high-flow nasal cannula therapy in patients with COPD and type II respiratory failure: a meta-analysis and systematic review. [2022]

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

The use of high-flow nasal cannula in patients with chronic obstructive pulmonary disease under exacerbation and stable phases: A systematic review and meta-analysis. [2023]

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

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

6. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of High Flow Nasal Therapy with Non-Invasive Ventilation and Conventional Oxygen Therapy for Acute Hypercapnic Respiratory Failure: A Meta-Analysis of Randomized Controlled Trials. [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

High Flow Through Nasal Cannula in Stable and Exacerbated Chronic Obstructive Pulmonary Disease Patients. [2020]

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

High-flow nasal cannula oxygen in adult patients: a narrative review. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical practice of high-flow nasal cannula oxygen therapy in adults: A Japanese cross-sectional multicenter survey. [2022]