High Flow Nasal Cannula for Endoscopic Ultrasound

Overseen By Anesthesia Clinical Research Unit

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: General anesthesia, Home oxygen, Severe COPD, others

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 examines whether high flow nasal cannula oxygen therapy is more effective than standard oxygen for individuals with a high BMI (body mass index of 35 or more) undergoing an endoscopic ultrasound. An endoscopic ultrasound uses a small camera to examine the digestive system. The study includes two groups: one receiving standard oxygen therapy and the other using the high flow nasal cannula. It seeks participants who are not on home oxygen therapy and are not undergoing complicated procedures, such as combined treatments. As an unphased trial, this study allows participants to contribute to important research that may enhance oxygen therapy options for individuals with a high BMI.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the high flow nasal cannula is safe for endoscopic ultrasound?

Research has shown that high flow nasal cannula (HFNC) oxygen therapy is generally safe. Studies have found that HFNC significantly reduces the risk of low oxygen levels during long endoscopic procedures, indicating it is well-tolerated by patients. Its common use in children with breathing problems further supports its safety. Although HFNC does not always eliminate the need for additional breathing support, it improves oxygen levels in many patients. Overall, HFNC is considered a safe method for providing oxygen during medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the high flow nasal cannula (HFNC) for endoscopic ultrasound because it offers a new way to deliver oxygen more effectively. Unlike standard oxygen therapy, which typically uses 2-4 liters of oxygen through a regular nasal cannula, the HFNC delivers oxygen at much higher flow rates with 100% oxygen concentration. This method can improve oxygenation during procedures, potentially enhancing patient safety and comfort. By providing a more controlled and efficient oxygen delivery, HFNC may reduce complications and improve outcomes during endoscopic procedures.

What evidence suggests that high flow nasal cannula is effective for endoscopic ultrasound?

This trial will compare the effectiveness of High Flow Nasal Cannula (HFNC) oxygen therapy with standard oxygen therapy during endoscopic ultrasound procedures. Studies have shown that HFNC can reduce low blood oxygen levels during endoscopy procedures. Specifically, one study found that HFNC significantly lowered the number of low oxygen cases compared to standard oxygen therapy in patients undergoing long upper gastrointestinal procedures. Another study demonstrated that HFNC helps maintain better oxygen levels during endoscopy with sedation. Although some research suggests it is not always superior to traditional methods, HFNC has shown potential benefits, particularly for high-risk patients. This treatment may deliver oxygen more effectively than standard nasal cannulas. ^{1 2 3 4 6}

Who Is on the Research Team?

Bhargavi Gali, MD, MHA

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for high-risk patients needing an endoscopy procedure. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high flow nasal cannula or standard oxygen therapy during endoscopic ultrasound

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recovery time and procedural conditions after the procedure

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• High Flow Nasal Cannula

Trial Overview The study is comparing two ways of delivering oxygen during an endoscopy: a high flow nasal cannula versus standard oxygen therapy. The goal is to see which method works better for patients who are considered at higher risk.

How Is the Trial Designed?

Group I: High Flow Nasal Cannula Experimental Treatment 1 Intervention

A high flow oxygen device with 100% FiO2 will be initiated prior to endoscopic ultrasound.

Group II: Standard oxygen therapy Active Control 1 Intervention

Standard oxygen therapy will be initiated utilizing 2-4 liters of oxygen with a nasal cannula.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Fisher and Paykel Healthcare

Industry Sponsor

Trials

127

Recruited

11,000+

Dr. Justin Vaughan

Fisher and Paykel Healthcare

Chief Medical Officer since 2024

MD from the University of Auckland

Lewis Gradon

Fisher and Paykel Healthcare

Chief Executive Officer since 2016

Bachelor of Science in Physics from the University of Auckland, New Zealand

Published Research Related to This Trial

The study involved 74 children aged 1 month to 5 years with acute respiratory distress, comparing a low-cost modified high-flow nasal cannula (HFNC) to a standard commercial HFNC.

Both systems showed similar effectiveness and safety in terms of intubation rates and adverse events, but nurses reported higher satisfaction with the commercial HFNC, suggesting that the modified version could be a viable alternative in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified high-flow nasal cannula for children with respiratory distress. Itdhiamornkulchai, S., Preutthipan, A., Vaewpanich, J., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2949708623000389

High-flow nasal cannula oxygen therapy versus ... The use of HFNC oxygen therapy significantly reduced the incidence of hypoxemia among our cohort of patients undergoing prolonged UGI endoscopic procedures.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06704867?term=AREA%5BConditionSearch%5D(echography)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=10

High Flow Nasal Cannula Compared to Standard Oxygen ... The purpose of the study is to evaluate the use of high flow nasal cannula versus standard oxygen therapy for high-risk patients undergoing endoscopy procedures ...

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-022-00661-8

The effectiveness of high-flow nasal cannula during sedated ... This meta-analysis evaluates the effectiveness of HFNC in patients undergoing digestive endoscopy procedures under sedation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8944360/

Comparative evaluation of efficacy of oxygenation using high ... HFNC use in patients undergoing EUS is not superior when compared to conventional nasal cannula oxygen therapy. HFNC failed to show any ...

5. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.949614/full

High flow nasal cannula for patients undergoing ... The outcomes extracted were: incidence of hypoxemia (defined as SpO2 < 90%), lowest oxygen saturation, partial pressure of carbon dioxide (CO2) ...

6. withpower.com withpower.com/trial/high-flow-nasal-cannula-for-endoscopic-ultrasound-d6afd

High Flow Nasal Cannula for Endoscopic Ultrasound High flow nasal cannula is increasingly used in pediatric care, especially for respiratory distress, and studies are exploring its safety and effectiveness.