Clinical trial NCT05592145: Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
Official title: Quantifying the Venous Congestion Curve of a Tissue Oximetry Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Op Complication
Skin Flap Necrosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The ViOptix machine will be used to measure the oxygenation of composite tissue.
Primary purpose: OTHER

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.

Detailed description: The rate of decline and pattern seen in tissue oxygenation as quantified by a NIRS device (ViOptiox T.Ox) can be quantified and described by a mathematical model which will allow earlier detection and identification of venous congestion in tissue. The vascular occlusion test has been established as a safe and accurate model to induce various states of vascular insufficiency and occlusion. Specifically the vascular occlusion test has been demonstrated to be an accurate model for inducing venous insufficiency on awake and aware patients. This study will aim to analyze the StO2 data output of the ViOptix in order to establish the earliest signs of tissue failure in various states of vascular compromise.

The purpose of this research study is to measure rate of decline and pattern of tissue oxygenation using the device, ViOptix T.Ox. The data collected will be used to formulate a mathematical model which will allow earlier detection and identification of venous congestion in tissue. Identifying these specific patterns will help to establish an evidence-based approach in recognizing specific problems and patterns associated with tissue compromise that can guide physicians to consider earlier flap salvage measures.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 volunteers

Exclusion Criteria:

* 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

Primary outcomes:
measure: Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours
timeFrame: Hour 0.5
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ramon Llull, MD
role: PRINCIPAL_INVESTIGATOR
References: