- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06704867
High Flow Nasal Cannula Compared to Standard Oxygen for Endoscopic Ultrasound
January 5, 2026 updated by: Bhargavi Gali, M.D., Mayo Clinic
High Flow Nasal Cannula Compared to Standard Oxygen Therapy for Endoscopic Ultrasound Procedure in High Risk Patients on Recovery Time and Procedural Conditions
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Patients with a higher BMI are at greater risk for lower oxygen levels which can delay the endoscopy procedure.
This research is being conducted to find out if high risk patients will have a shorter recovery time and improved procedural conditions with a high flow nasal cannula versus standard oxygen therapy.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55901
- Mayo Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• All patients age 18 years and older who present to Gonda 2 procedural area for Endoscopic ultrasound (EUS) with or without endoscopy (EGD)/biopsy/tissue sampling. with BMI ≥ 35 kg/m2 (BMI within the past 6 months in electronic medical records or at current procedure) who are able to consent will be approached for potential enrollment.
Exclusion Criteria:
- Need for general anesthesia for the procedure instead of the standard monitored anesthesia care.
- Patients undergoing combined procedure: Therapeutic EUS/combined procedures including EUS/ERCP, EUS/colonoscopy
- Patients on home oxygen therapy, or the diagnosis of "severe COPD"
- Patients with existing tracheostomy
- Inpatients undergoing EUS
- Inability to consent
- Cognitive impairment
- Blocked nasal passages
- Trauma/previous surgery to the nasopharynx
- Irregularities of the nose, face, or airway such that HFNC cannot be properly fitted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard oxygen therapy
Standard oxygen therapy will be initiated utilizing 2-4 liters of oxygen with a nasal cannula.
|
|
|
Experimental: High Flow Nasal Cannula
A high flow oxygen device with 100% FiO2 will be initiated prior to endoscopic ultrasound.
|
Subjects undergoing endoscopic ultrasound will receive high flow nasal cannula during the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease recovery time
Time Frame: 4 hours
|
Time measured in minutes for participants to enter post anesthesia care until the nurse marks "ready for discharge" in the medical record.
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improve procedural conditions
Time Frame: 1 hour
|
Decreased number of times the procedure is paused or delayed.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Bhargavi Gali, MD, MHA, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 14, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
November 20, 2024
First Submitted That Met QC Criteria
November 25, 2024
First Posted (Actual)
November 26, 2024
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 5, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 24-003924
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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