High-flow Nasal Oxygen Therapy for Hypoxia

MS
Overseen ByMaximilian S. Schaefer, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.23678

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.
See 6 more

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?
2Treatment groups
Active Control
Group I: Control groupActive Control1 Intervention
Group II: Intervention groupActive Control1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

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 ...
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% ...
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 ...
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 ...
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 ...
A Comprehensive Review on High-Flow Nasal Cannula ...This review comprehensively evaluates HFNC therapy, focusing on its definition, historical evolution, and current clinical applications.
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 ...
High-flow nasal cannula oxygen therapyA meta-analysis of 14 randomized controlled trials (n = 1,012) showed that HFNC pre-oxygenation improved arterial PaO2 (mean difference ≈ 57 mm Hg) and ...
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