Quantifying the Venous Congestion Curve of a Tissue Oximetry Device

NCT05592145 | Completed Results FDA Device

• 1 other identifier: IRB00090046
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. ViOptix probes will be secured to the arm and hand. The recording process on the ViOptix machine will begin and obtain baseline StO2 levels for 5 minutes. After 5 minutes, a blood pressure cuff will be inflated on one arm. This blood pressure cuff will be left inflated for 10-20 minutes. Every 2 minutes a pulse check or doppler exam will be performed at your wrist. Last, the cuff will be deflated and the you will be free to leave the study room.

Conditions

Post-Op Complication; Skin Flap Necrosis

Outcome Measures

Primary Outcomes (1)

• Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours

  transcutaneous oximetry (StO2) of vascular occlusion test at 0.5 hours - an StO2 greater than 55 mmHg is considered normal regardless of the site of measurement

  Hour 0.5

Study Arms (1)

ViOptix T.Ox

OTHER

ViOptix T.Ox machine is used to measure the oxygenation of composite tissue.

Device: ViOptix

Interventions

ViOptix DEVICE

ViOptix machine

ViOptix T.Ox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 volunteers

You may not qualify if:

• Subjects with a history of major cardiac disease, peripheral vascular disease including (vascular insufficiency), Raynaud syndrome, blood dyscrasias, pain syndromes, neurologic conditions, major upper extremity soft tissue trauma or previous vascular injury

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Renea Jennings RN,BSN,CCRP
• Organization: Atrium Health Wake Forest Baptist

rjenning@wakehealth.edu

336-716-4417

Study Officials

• Ramon Llull, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ViOptix machine will be used to measure the oxygenation of composite tissue.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: November 10, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 21, 2024
• Results First Posted: March 20, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)