Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access

• Sponsor: Mayo Clinic (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04922606
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 51.6
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the anatomy of the great saphenous vein at the level of the medial thigh in the general population in an effort to categorize this as a reliable target vessel for rescue peripheral IV access.

Condition or Disease	Intervention/Treatment	Phase
Anatomy of the GSV for Rescue Peripheral IV Access	Diagnostic Test: US ot the GSV	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Great Saphenous Vein Anatomy at the Proximal Medial Thigh as a Potential Site for Rescue Venous Access
• Actual Study Start Date: May 4, 2021
• Anticipated Primary Completion Date: May 7, 2025
• Anticipated Study Completion Date: Aug 22, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: US of GSV Ultrasound of the Great Saphenous Vein	Diagnostic Test: US ot the GSV; Ultrasound of the Great Saphenous Vein

Outcome Measures

Primary Outcome Measures

1. Successful visualization of GSV [12 months]

   Number of times the great saphenous vein is identified at the level of the medial distal thigh in the general population using ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pediatric and adult Emergency Department patients and employees of all ages from all areas of the emergency department or additional training sites staffed by emergency medicine residents.

Exclusion Criteria:

• Critically ill patients as determined by the Emergency Medicine consultant of record for the patient.

• Legs not accessible due to dressing, wounds, or other factors.

• Overlying cellulitis/soft tissue infection or injury.

• Patients that are prison inmates and patients/patient's surrogates who are unable to give verbal consent/assent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Tobias Kummer, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Tobias Kummer, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04922606
• Other Study ID Numbers: 21-002859
• First Posted: Jun 10, 2021
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 15, 2022