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Clinical EvidenceResearch Study Results Underscore the Efficacy of ViOptix T.Ox Tissue Oximeter for Microsurgical Flap Assessment and Monitoring Publication of T.Ox Clinical Study The results of a clinical study in the field of plastic and reconstructive surgery where the ViOptix T.Ox Tissue Oximeter was used were recently published in a peer-reviewed journal. “A New Diagnostic Algorithm for Early Prediction of Vascular Compromise in 208 Microsurgical Flaps Using Tissue Oxygen Saturation Measurements”, Alex Keller, MD, Annals of Plastic Surgery: May 2009, Volume 62, Issue 5, pp. 538-543. Criteria studied in various combinations were the absolute value of tissue oxygen saturation (StO2), the amount of its change (DStO2) , and the rate of its change (DStO2/Dt). 208 flaps were monitored. Five patients exhibited complications predicted by the tissue oximeter before clinical signs were evident 8 additional surgeries performed for vascular problems (2 Hematoma, 4 Venous, 2 Arterial). The new algorithm predicted post-op complications within one hour of the onset of the occlusive event. The investigator concluded that T.Ox facilitates detection of vascular complications before they are clinically apparent; that salvaged flaps should have less fat necrosis because ischemic time can be shortened and no flap being monitored was lost. Click here to view the PubMed Abstract (a link to an external site) The following T.Ox research findings were presented at the 2009 annual meeting of the American Society for Reconstructive Microsurgery by clinicians and scientists from leading institutions: Comparison of T.Ox to Implantable Doppler Robert Lohman, MD from the Cleveland Clinic Foundation presented the results of a study “Methods of Free Flap Monitoring in a Non- Specialized Unit” comparing different methods of free flap monitoring: clinical and hand held surface Doppler examination by the routine nursing staff, Implantable Doppler, and Tissue Oximetry (ViOptix T.Ox). In this study of 38 free flap patients, T.Ox Tissue Oximetry detected complications first in all 5 out of 5 complications; T.Ox had no false negatives and no false positives and T.Ox identified flaps with vascular compromise one hour earlier than the internal Doppler. The researchers further concluded that T.Ox allows early transfer of patients to the floor and care by less experienced nursing personnel. Pre-Operative Imaging with T.Ox Risal Djohan, MD from the Cleveland Clinic presented results of their study on pre-operative imaging and T.Ox in DIEP flap breast reconstruction. T.Ox data was used to supplement information from CT Angiogram to help determine
the selection of the optimal perforator or specific branches of perforators.
T.Ox was also used to measure flap perfusion status at the donor site intraoperatively
to help identify areas of greater or lesser perfusion in order to assist in trimming
and shaping the flap. The study concluded that T.Ox confirmed the findings of CTA and enabled more precise design and harvest of flaps, and may ultimately lead to flaps that are more reliable with potentially less risk of fat necrosis. Detection and Classification of Perfusion Differences in a Partial Venous Obstruction ModelFrom the University of Wisconsin, John Russell, MS, presented a study evaluating the relationship between venous stenosis and tissue oxygen saturation in an animal flap model. The research concluded that T.Ox is an accurate quantitative method for monitoring flap perfusion and for assisting with the determination of the presence of venous congestion. T.Ox detected partial venous restriction with corresponding reductions in StO2. Measurement of Normal Flap Physiology in 236 Perforator Free Flaps T.Ox tissue oxygen saturation measurements were taken by Alex Keller, MD, of North Shore Long Island Jewish Health System, to make observations concerning normal and abnormal flap physiology, intraoperatively and in post-operative monitoring in 236 perforator free flaps. Observations from this study include: · During flap elevation and division real-time StO2 measurements reflected a drop in StO2, followed by a recovery of StO2 upon revascularization · T.Ox was used as an intraoperative tool to identify areas of lesser or greater perfusion across the perforator flap and to assist in selection of tissue with the best chance of survival · T.Ox measurements were taken on skin flaps post-mastectomy to help differentiate between poorly perfused tissue and tissue that may be bruised but is still viable · Supplemental oxygen increased local tissue StO2 levels, even with no change in Pulse Ox readings · Extubation decreased StO2 · Mild pressure on the flap did not change StO2 · Changes in patient position such as getting out of bed can cause a decrease in the StO2 · A venous occlusive event is usually preceded by a short period of elevated StO2, followed by a gradual decline · An arterial occlusion will show a direct decline in StO2 that levels off at significantly lower levels, reflecting residual blood remaining in the venous system |
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