High Flow Nasal Cannula Compared to Standard Oxygen for Endoscopic Ultrasound
1 other identifier
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
November 26, 2024
CompletedStudy Start
First participant enrolled
July 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 7, 2026
January 1, 2026
1.1 years
November 20, 2024
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease recovery time
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 Outcomes (1)
Improve procedural conditions
1 hour
Study Arms (2)
Standard oxygen therapy
NO INTERVENTIONStandard oxygen therapy will be initiated utilizing 2-4 liters of oxygen with a nasal cannula.
High Flow Nasal Cannula
EXPERIMENTALA high flow oxygen device with 100% FiO2 will be initiated prior to endoscopic ultrasound.
Interventions
Subjects undergoing endoscopic ultrasound will receive high flow nasal cannula during the procedure
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Fisher and Paykel Healthcarecollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55901, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Bhargavi Gali, MD, MHA
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 20, 2024
First Posted
November 26, 2024
Study Start
July 14, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share