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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViOptix T.Ox | Other | ViOptix T.Ox machine is used to measure the oxygenation of composite tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ViOptix | Device | ViOptix machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramon Llull, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ViOptix T.Ox | ViOptix T.Ox machine is used to measure the oxygenation of composite tissue. ViOptix: ViOptix machine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ViOptix T.Ox | ViOptix T.Ox machine is used to measure the oxygenation of composite tissue. ViOptix: ViOptix machine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | percentage of oxygen saturation | Hour 0.5 |
|
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Each participant was in the study and monitored for adverse events for approximately one hour on the day the study activities occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ViOptix T.Ox | ViOptix T.Ox machine is used to measure the oxygenation of composite tissue. ViOptix: ViOptix machine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renea Jennings RN,BSN,CCRP | Atrium Health Wake Forest Baptist | 336-716-4417 | rjenning@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2023 | Jan 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2023 | Nov 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The ViOptix machine will be used to measure the oxygenation of composite tissue.
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
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