N/A N=38 Other

Quantifying the Venous Congestion Curve of a Tissue Oximetry Device

Post-Op Complication · Skin Flap Necrosis

Bottom Line

View on ClinicalTrials.gov: NCT05592145 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours — 70.353 percentage of oxygen saturation

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ViOptix (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wake Forest University Health Sciences
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Transcutaneous Oximetry (StO2) of Vascular Occlusion Test at 0.5 Hours	70.353	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05592145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.