High-flow Nasal Oxygen Therapy for Hypoxia

Overseen By Maximilian S. Schaefer, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Pregnancy, COVID-19, General anesthesia

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

180 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 High-flow Nasal Oxygen Therapy for hypoxia?

Research shows that High-flow Nasal Cannula (HFNC) therapy is effective in providing oxygen to patients with respiratory failure and is better than low-flow methods in reducing low oxygen events during procedures. It is commonly used in critical care settings and has shown beneficial effects in patients with acute respiratory failure. ^{1 2 3 4 5}

Is high-flow nasal oxygen therapy safe for humans?

High-flow nasal oxygen therapy (HFNC) is generally considered safe for humans, with studies showing it can improve oxygenation in adults with severe respiratory conditions. Some common side effects include nosebleeds, nasal discomfort, and dryness, but no unexpected side effects have been reported. ^{2 3 4 6 7}

How is high-flow nasal oxygen therapy different from other treatments for hypoxia?

High-flow nasal oxygen therapy (HFNO) is unique because it delivers a constant, high flow of oxygen through a nasal cannula, which can provide better oxygenation and comfort compared to low-flow systems. It is non-invasive and can be used outside of intensive care settings, making it more accessible for patients with respiratory issues. ^{1 3 4 6 8}

What is the purpose of this trial?

Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, sedation during endoscopy carries a serious risk of blood oxygen desaturation. This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.

Eligibility Criteria

This trial is for high-risk patients needing upper GI endoscopy, who may experience low blood oxygen during the procedure. Participants should not have conditions that exclude them from safely receiving high-flow nasal oxygen therapy.

Inclusion Criteria

BOSTN score ≥ 2

I have been diagnosed with sleep apnea.

I snore loudly.

Exclusion Criteria

I currently have COVID-19.

I am scheduled for surgery under general anesthesia.

Known Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-risk upper GI endoscopy with either standard care or high-flow nasal oxygen therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

Treatment Details

Interventions

• High-flow Nasal Oxygen Therapy

Trial Overview The study tests if using high-flow nasal oxygen (HFNO) can prevent blood oxygen levels from dropping too low during an upper GI endoscopy compared to standard care. Patients are randomly assigned to either receive HFNO or standard care while being monitored.

Participant Groups

Group I: Control group Active Control 1 Intervention

Supplemental oxygen throughout anesthesia in accordance with hospital guidelines.

Group II: Intervention group Active Control 1 Intervention

HFNO- treatment

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Findings from Research

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]

In a study of 75 adult patients with acute hypoxemic respiratory failure, 62.7% successfully avoided intubation when treated with high-flow nasal cannula (HFNC) therapy, indicating its efficacy in improving respiratory function.

HFNC therapy significantly improved key physiological parameters like oxygen levels and respiratory rate within the first 24 hours, but failure to improve oxygenation during this time was a strong predictor of the need for intubation and higher ICU mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula Therapy for Acute Hypoxemic Respiratory Failure in Adults: A Retrospective Analysis. Hyun Cho, W., Ju Yeo, H., Hoon Yoon, S., 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]

A systematic review and meta-analysis of six randomized control trials involving 1,170 patients showed that high-flow nasal cannula (HFNC) oxygenation significantly reduces hypoxemic events and procedural interruptions during bronchoscopy compared to low-flow nasal cannula (LFNC).

The benefits of HFNC in preventing hypoxemia were still evident 10 minutes after the procedure, suggesting its effectiveness in enhancing patient safety during and after bronchoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Flow vs. Low-Flow Nasal Cannula in Reducing Hypoxemic Events During Bronchoscopic Procedures: A Systematic Review and Meta-Analysis. Sampsonas, F., Karamouzos, V., Karampitsakos, T., et al.[2022]

High flow nasal cannula oxygen (HFNC) significantly improved respiratory function in ICU patients with acute respiratory failure, showing benefits like reduced respiratory rate and increased oxygen levels within just 15 minutes of use.

HFNC was well-tolerated with no cases of pneumonia reported, and while some patients eventually required invasive mechanical ventilation, the treatment demonstrated a positive impact on clinical signs and oxygenation, suggesting it may help reduce the need for intubation in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. Sztrymf, B., Messika, J., Bertrand, F., et al.[2022]

In a study of 82 COPD patients with moderate hypercapnic acute respiratory failure, high-flow nasal cannula (HFNC) therapy showed a treatment failure rate of 28.2%, which was not significantly different from the 39.5% failure rate observed with non-invasive ventilation (NIV).

HFNC therapy resulted in fewer nursing airway care interventions and lower rates of skin breakdown compared to NIV, suggesting it may be a more comfortable option for patients in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease with acute-moderate hypercapnic respiratory failure: an observational cohort study. Sun, J., Li, Y., Ling, B., 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]

In a study involving 35 healthy volunteers, factors such as nasal cannula diameter, flow rate, sex, and height were found to significantly influence the nasal airway pressure during high-flow nasal cannula (HFNC) oxygen therapy.

The study also revealed that while larger cannula diameters increased discomfort during expiration, there was no significant difference in comfort levels between two different HFNC devices, highlighting the importance of selecting appropriate equipment and settings for patient comfort and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors influencing nasal airway pressure and comfort in high-flow nasal cannula oxygen therapy: a volunteer study. Zhao, E., Zhou, Y., He, C., et al.[2023]

References

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

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

2. Japan pubmed.ncbi.nlm.nih.gov

High-Flow Nasal Cannula Therapy for Acute Hypoxemic Respiratory Failure in Adults: A Retrospective Analysis. [2022]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

High-Flow vs. Low-Flow Nasal Cannula in Reducing Hypoxemic Events During Bronchoscopic Procedures: A Systematic Review and Meta-Analysis. [2022]

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

Beneficial effects of humidified high flow nasal oxygen in critical care patients: a prospective pilot study. [2022]

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

High flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease with acute-moderate hypercapnic respiratory failure: an observational cohort study. [2020]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Factors influencing nasal airway pressure and comfort in high-flow nasal cannula oxygen therapy: a volunteer study. [2023]