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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-flow nasal oxygen therapy can maintain stable oxygen levels during an upper GI endoscopy. Sedation for this procedure often causes a drop in blood oxygen, which this therapy aims to prevent. Participants will receive either the standard oxygen treatment or high-flow nasal oxygen therapy to determine which is more effective. Individuals with sleep apnea, high BMI (body mass index), or low baseline oxygen levels may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance procedural safety for many patients.

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 prior data suggests that high-flow nasal oxygen therapy is safe for use during high-risk gastroscopy?

Research has shown that High-flow Nasal Oxygen Therapy (HFNO) is generally safe for people. Studies have found that patients using HFNO experience better breathing and higher oxygen levels. For instance, a review of several studies found that HFNO increased blood oxygen levels by an average of 57 mm Hg, indicating improved oxygenation.

Additionally, HFNO often provides more comfort compared to other oxygen delivery methods. While minor side effects like a dry nose or slight discomfort may occur, serious problems are rare. This treatment has been safely used in various situations, including for patients with severe breathing issues.

In summary, current research supports HFNO as a safe and well-tolerated option, making it reliable for improving oxygen levels during procedures like endoscopy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High-flow Nasal Oxygen Therapy (HFNO) for hypoxia because it offers a unique approach compared to standard oxygen therapy methods. Unlike traditional low-flow oxygen delivery, HFNO provides a higher flow of oxygen, which can better meet the body's demands and improve oxygenation more effectively. This method is also more comfortable for patients, as it delivers warm, humidified air, reducing the irritation often caused by conventional oxygen masks. Additionally, HFNO can be used continuously during various medical procedures, potentially reducing the risk of hypoxia in critical situations.

What evidence suggests that high-flow nasal oxygen therapy is effective for reducing hypoxia during gastroscopy?

Research has shown that high-flow nasal oxygen therapy (HFNO), which participants in this trial may receive, can assist people with breathing problems. Studies have found that HFNO improves oxygen levels and eases breathing. It has been linked to better survival rates in severe cases. In one study, HFNO reduced death rates from 23% and 28% to just 12%. Additionally, HFNO provides warm and moist oxygen, making breathing more comfortable. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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

BMI ≥ 30 kg/m2

I have been diagnosed with sleep apnea.

Exclusion Criteria

I currently have COVID-19.

I am scheduled for surgery under general anesthesia.

Known Pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 (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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9622568/

Clinical outcomes of high-flow nasal cannula oxygen therapy ... HFNC therapy could significantly improve several objective parameters over time such as RR, left ventricular function, and ABG reflection of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667100X22000767

Review High-flow nasal cannula oxygen therapy in acute ... Among the 313 patients included in the trial, results showed significant differences in favor of HFNC in terms of mortality (12% vs. 23% and 28% ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1503326

High-Flow Oxygen through Nasal Cannula in Acute ... In conclusion, treatment with high-flow oxygen improved the survival rate among patients with acute hypoxemic respiratory failure, even though ...

4. jtd.amegroups.org jtd.amegroups.org/article/view/18837/html

Effectiveness of high-flow nasal cannula oxygen therapy for ... All patients showed clear improvement in hypercapnia after HFNC application, except the patients with extrapulmonary ALI and sleep apnea. Furthermore, we ...

5. cureus.com cureus.com/articles/282755-a-comprehensive-review-on-high-flow-nasal-cannula-oxygen-therapy-in-critical-care-evidence-based-insights-and-future-directions

A Comprehensive Review on High-Flow Nasal Cannula ... HFNC provides heated and humidified oxygen at high flow rates, which can improve oxygenation and reduce the work of breathing. It has shown ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11375959/

A Comprehensive Review on High-Flow Nasal Cannula ... This review comprehensively evaluates HFNC therapy, focusing on its definition, historical evolution, and current clinical applications.

7. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/impact-of-high-flow-nasal-oxygen-in-patients-with-acute-hypoxic-respiratory-failure-in-emergency-department-4238/

Impact of High Flow Nasal Oxygen in Patients with Acute ... Results: HFNC resulted in significantly faster improvement in respiratory and oxygenation parameters and significantly higher patient comfort ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1661569/full

High-flow nasal cannula oxygen therapy A meta-analysis of 14 randomized controlled trials (n = 1,012) showed that HFNC pre-oxygenation improved arterial PaO2 (mean difference ≈ 57 mm Hg) and ...