Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 4:39 PM
Study NCT ID:
NCT06704867
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-13
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula Compared to Standard Oxygen for Endoscopic Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease recovery time', 'timeFrame': '4 hours', 'description': 'Time measured in minutes for participants to enter post anesthesia care until the nurse marks "ready for discharge" in the medical record.'}], 'secondaryOutcomes': [{'measure': 'Improve procedural conditions', 'timeFrame': '1 hour', 'description': 'Decreased number of times the procedure is paused or delayed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Flow Nasal Cannula', 'High BMI', 'Oxygen'], 'conditions': ['Endoscopic Ultrasound']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• 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.\n\nExclusion Criteria:\n\n* Need for general anesthesia for the procedure instead of the standard monitored anesthesia care.\n* Patients undergoing combined procedure: Therapeutic EUS/combined procedures including EUS/ERCP, EUS/colonoscopy\n* Patients on home oxygen therapy, or the diagnosis of "severe COPD"\n* Patients with existing tracheostomy\n* Inpatients undergoing EUS\n* Inability to consent\n* Cognitive impairment\n* Blocked nasal passages\n* Trauma/previous surgery to the nasopharynx\n* Irregularities of the nose, face, or airway such that HFNC cannot be properly fitted'}, 'identificationModule': {'nctId': 'NCT06704867', 'briefTitle': 'High Flow Nasal Cannula Compared to Standard Oxygen for Endoscopic Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'High Flow Nasal Cannula Compared to Standard Oxygen Therapy for Endoscopic Ultrasound Procedure in High Risk Patients on Recovery Time and Procedural Conditions', 'orgStudyIdInfo': {'id': '24-003924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard oxygen therapy', 'description': 'Standard oxygen therapy will be initiated utilizing 2-4 liters of oxygen with a nasal cannula.'}, {'type': 'EXPERIMENTAL', 'label': 'High Flow Nasal Cannula', 'description': 'A high flow oxygen device with 100% FiO2 will be initiated prior to endoscopic ultrasound.', 'interventionNames': ['Other: High flow nasal cannula']}], 'interventions': [{'name': 'High flow nasal cannula', 'type': 'OTHER', 'description': 'Subjects undergoing endoscopic ultrasound will receive high flow nasal cannula during the procedure', 'armGroupLabels': ['High Flow Nasal Cannula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55901', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Bhargavi Gali, MD, MHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bhargavi Gali, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}