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

200 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.

What data supports the effectiveness of the treatment High Flow Nasal Cannula for Endoscopic Ultrasound?

High flow nasal cannula (HFNC) has been shown to be effective in improving oxygenation in patients during procedural sedation for endoscopic ultrasound, as well as in managing respiratory distress in other settings like pediatric and emergency care. It offers advantages over conventional oxygen therapy, such as better oxygen delivery and reduced risk of nasal trauma. ^{1 2 3 4 5}

Is high flow nasal cannula generally safe for use in humans?

High flow nasal cannula is increasingly used in pediatric care, especially for respiratory distress, and studies are exploring its safety and effectiveness. While there is limited information on its use outside intensive care, research is ongoing to ensure safe application and to understand potential risks. ^{1 2 6 7 8}

How does the high flow nasal cannula treatment differ from other treatments for endoscopic ultrasound?

The high flow nasal cannula (HFNC) treatment is unique because it delivers a high flow of oxygen, which can improve oxygenation more effectively than conventional nasal cannulas during procedures like endoscopic ultrasound. This method is noninvasive and provides better access to patients while reducing the risk of nasal trauma compared to other oxygen delivery systems. ^{1 3 4 5 9}

What is the purpose of this trial?

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.

Research Team

Bhargavi Gali, MD, MHA

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

A case series of paediatric high flow nasal cannula therapy. [2013]

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

The Clinical Impact of Heated Humidified High-Flow Nasal Cannula on Pediatric Respiratory Distress. [2022]

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

High-Flow Nasal Cannula Versus Conventional Oxygen Therapy in Emergency Department Patients With Cardiogenic Pulmonary Edema: A Randomized Controlled Trial. [2020]

4. India pubmed.ncbi.nlm.nih.gov

Comparative evaluation of efficacy of oxygenation using high flow nasal cannula vs. conventional nasal cannula during procedural sedation for endoscopic ultrasound: A pilot study. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Use of high-flow nasal cannula in neonates: Nationwide survey in Japan. [2018]

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

High flow nasal cannula use outside of the ICU; factors associated with failure. [2018]

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

Factors Associated With Failure of High-Flow Nasal Cannula. [2021]

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

A Novel Weaning Protocol for High-Flow Nasal Cannula in the PICU. [2019]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

Modified high-flow nasal cannula for children with respiratory distress. [2022]