ࡱ>  @bjbj %jj:lj j j j , t+(!(>!>!>!>!>!>!>!#+%+%+%+%+%+%+$, /I+->!>!>!>!>!I+p(>!>!v+p(p(p(>!>!>!#+p(>!#+p(Tp(()#+>! ! Քj 'N+#++0++/`(/#+p(Skin Temperature and Chronic Venous Insufficiency NEW Modalities in Evaluation of CVI Teresa J. Kelechi, PhD, APRN-BC, CWCN HYPERLINK "http://www.musc.edu/~kelechtj/cvi/"http://www.musc.edu/~kelechtj/cvi/ HYPERLINK "http://www.musc.edu/~kelechtj/foot/"http://www.musc.edu/~kelechtj/foot/ Objectives Current thinking on pathological processes Skin temperature and microcirculation Evaluation methods Diagnostic and clinical Application of thermometry Temperature as a prediction model Skin temperature vital sign Trends in interventions/innovations Chronic venous insufficiency Venous hypertension affects deep and/or superficial venous system (Schmid-Schonbein, 2001) Valvular incompetence (physical change) Reflux (ulcer risk highest with 15 ml/sec) Venous obstruction (thrombus/iliac stenosis) Clinical manifestations: Telangiectasis, varicose veins, edema Cutaneous hyperpigmentation, dermatitis Subcutaneous tissue fibrosis (lipodermatoscerlosis) Intractable ulceration Primary venous insufficiency Dysfunction of venous valves Elevated distal venous pressure Without skin and subcutaneous tissue changes Superficial venous insufficiency, with or without perforating vein reflux most common anatomic distribution pattern associated with primary CVI (Ioannou, 2003) Deep vein insufficiency most commonly present in limbs with post-thrombotic CVI (92%) Pathological processes Early events Venous hypertension Thrombosis Calf muscle pump dysfunction Iliac vein stenosis Iliac vein outflow obstruction with reflux (Raju, 2002) Vessel wall damage (inflammation) ***No direct links have been established between venous hypertension and actual tissue damage (Duran, 2000) Middle events Endothelial distention under the influence of elevated venous pressure Abnormal deposition of collagen in both vein wall and skin Shift in fluid shear stress from normal physiological levels Mechanical tissue stresses - hydrostatic pressure in the tissues (Duran, 2000) Hypoxia failure of oxygen delivery to the tissues Late events Microcirculatory inflammation (hostile) Leukocyte activation expression of soluble and other adhesion molecules inhibition of metalloproteinases Perivascular infiltration of monocytes, mast cells, macrophages and connective tissue proteins (fibrin) into the capillaries of the papillary plexus (most superficial part of dermis) - Perivascular fibrin cuff and white blood cell trapping theories Late events Skin pathology Defective fibrinolysis at the systemic level PAI 1 activity and LPA damage to endothelium thrombotic potential (Blomgren, 2001) Does the thrombotic even lead to CVI or CVI increase the potential for the thrombotic event? Triggers for skin pathology What does the skin become impaired in some, but not in others?? The underlying defect may be occult or sub-clinical and triggered by: Bacterial and fungal infections Dietary (hypercholesterolemia) Hormonal influence (progesterone) Environmental factors (leg injury, surgery) Risk factors Inconsistent data (Mosti, 2000) Hereditary/genetic link (Pistorius, 2003) Prolonged standing or sitting (Jawien, 2003) Change in hormonal milieu Gender height Prevalence with age Obesity: BMI >40 (Padgerg, 2003) Stronger link Pregnancy (2 or more) Bowel habits (Treiman, 2001) Lack of physical activity Risk factors Strongest link with DVT Combined arterial and venous insufficiency (CAVI) ulcers have longest healing times, reoccur most frequently, and many are unlikely to heal even with surgical intervention Reflux > 15 ml/sec Wounds wont heal Predicts wound development (Mosti, 2000) Other: History of leg injury (Lacroix, 2003) Signs and symptoms Heaviness, tension, feeling of swelling, tingling, aching, itching, cramps, venous claudication (relieved with elevation) severity, symptoms????? Assess quality of life using Chronic Venous Insufficiency Questionnaire (CIVIQ) (Lorzano, 2002) Available in Spanish Classification CEAP Beebe (1995, 2003) currently under revision Clinical signs (0 6) Etiology Anatomical distribution Pathophysiological dysfunction Severity score Good description can be found in Angiology, 52 (1), Antignani (2001) Widmer BASLE III Study (1978) 3 stages Porter (McEnroe, 1988; Iafrati, 1994) 4 stages Is there a role for skin temperature? Clinical observations Skin felt warmer over areas where patients complained of burning, itching Skin temperature Regional (Niu, 2001) Neck is warmest (forehead) Toes are coolest (bottom of foot 84F) Side to side variation (.5C) Average skin temperature slightly lower in elderly, especially distal parts of extremities Temperature oscillations (variability) originate from vasomotor smooth muscle activity in the small arterioles and arteries in the subcutaneous tissue (Shusterman, 1997) Skin Temperature Thermoregulation (Charkoudian, 2003) Circulation (cutaneous blood flow/tissue oxygenation) Inflammation What is being measured?? Circulation at the subpapillary dermis level at one small localized area of skin (not body or core temperature) What are the internal and external environmental factors that influence skin temperature? Factors affecting skin temperature Tsk Room temperature - thermoneutral 21 - 23C (77 81F) Air movement - turbulence that disrupts the barrier/boundary layer of air (Cimini, 2003) Seasonal variation Relative humidity normal = 50%, dry = 20%, humid = 80% Factors affecting Tsk Food intake thermogensis (impaired in diabetes Tsk returns to normal more quickly) Drugs: propanolol (Vandenburg, 1981), NSAIDs Cormorbidity: Chronic depression, diabetes, neuropathy Sensory/autonomic - Tsk, > orthostatic BP fall (13 mmHg) (Boyko, 2001) Polyneuropathy Tsk mirrors ambient temperature (Hoffman, 2003) Diurnal patterns (lower at night) Glabrous (nonhair) Tissue oxygen in CVI Data are conflicting (Stucker, 2000; Wipke-Tevis, 2002) Heterogenous distribution is impaired in CVI Is the tissue oxygen increased or decreased in the affected leg (regional)? Is tissue oxygen increased or decreased in the affected skin (local): Varicose veins Dermatitis? Lipodermatosclerosis? Hyperpigmentation? Tissue oxygenation Heterogeneous oxygenation exists in human skin even at near normal (steady state) or ambient temperature (Havada, 1998) Different types of capillary supply units exist in human skin (indicated by different oxygen levels) These different supply units operate to produce a local redistribution of flow between the various capillary supply units Heterogeneity of skin blood flow patterns emerge under different environmental conditions (Harrison, 2002) Skin temperature and tissue oxygen What is the relationship? Does skin temperature reflect tissue oxygen/cutaneous blood flow? Clinically does dermal skin temperature measurement reflect microvascular circulation in localized areas of the skin? Can Tsk serve as a vital sign or prodromal sign of an impending ulcer? Are skin temperature changes predictive of ulceration? Skin temperature in CVI Higher?? (Kelechi, 2003) Is there a difference between regional and local Tsk? Is there a difference between regional and local tissue oxygen? Is there a difference between type or stage or grade of CVI and Tsk? Is there a relationship between Tsk and tissue oxygen in skin affected by CVI? Whats the issue? Need to establish a method for screening for heterogeneous disturbances in blood flow in skin affected by venous insufficiency as a clinical assessment parameter The screening device should be portable, easy to use, valid, reliable What is the current standard of care for diagnostic/clinical assessment? How is the etiology of edema evaluated? Cardiac, venous, renal, lymphatic, adverse effects of meds What is the hallmark of venous insufficiency? A sign or a symptom? Methods to evaluate Macrovascular (conventional method) Duplex scanning deep and superficial veins Venous reflux Establish incompetence of valves Edema ?????? Methods to evaluate Microvascular Photoplethysmography (PPG) air/strain gauge (Allen, 2002) Venous occlusive plethysmography Microvascular volume, pulsatility, capillary filtration Laser doppler flowmeter (LDF) or imager(LDI) Microvascular flux in tissue, viability, perfusion Transcutaneous partial oxygen and carbon dioxide (TcPO2 and TcPCO2) Methods to evaluate Skin temperature (Tsk) Noncontact infrared Contact thermistors, thermocouples Mercury in glass Tympanic infrared Optic/radiation Liquid crystal Thermographic imagers What do the data suggest so far? Two studies of the level of agreement between two infrared thermometers and a thermistor: #1, a high level of agreement (within 0.3C of the thermistor) was found between ThermoTrace (DeltaTrak) and thermistor (J&J Medical) #2, low level between new device ($80), TT ($500) and thermistor (> .5C) new device overestimated skin temperature by 1.9C Need to set clinical acceptable difference Need to have certificate of calibration Need to test against a water bath Sample Convenience sample: N = 34 Ages 30 to 80 17 females 17 males Inclusion criteria No known vascular or endocrine disease ABI > .90 Blood pressure (orthostatic), oral temperature Not taking NSAIDs, ASA, antidepressants, beta blockers Procedures Clinically acceptable difference 1F (Holtzclaw 1993; 1995) Need to use celsius Need to set a smaller difference for dermal thermometry < 0.15C (Fallis, 1999; McKenzie, 2003) Environment Thermoneutral, draft-free Time of day: 9 to 11 AM Season: summer Procedure Mark test site (antecubital fossa) Acclimatize for 10 minutes (10 30 minutes required for acclimatization) Sheet placed over entire body including extremities Temperature recorded after 1 minute (Time 1); readings taken 1 inch from skin Repeated after another minute (Time 2) Findings ThermoTrace: Validity The ThermoTrace can be used interchangeably with the thermistor Mean difference between ThermoTrace and thermistory was .06F (average of all 34 thermistor readings minus the average readings of all 34 ThermoTrace at Time 1) (Bland & Altman, 1986; 1995) Upper limit was 0.4669 Lower limit was 0.582 Findings ThermoTrace: Reliability The ThermoTrace yielded reliable (repeatable) results from Time 1 to Time 2 Clinically acceptable difference set at 0.25F Mean difference -0.16F and the standard deviation was 0.06F Studies Skin temperature is elevated in individuals with Stage 4 and 5 CVI by 1.8F. n = 26 with CVI (Stage 4 and 5 CEAP) N = 26 without CVI Average lower leg skin temperature (gaiter area) affected by CVI = 89F Significant differences found between four sites on the lower legs between the 2 groups However, is it a clinically significant difference??? Studies Study of Tsk and TcPO2 in CVI stages 4 and 5 and normal individuals n = 15 with CVI (stages 4 and 5 CEAP) n = 8 without CVI Hypothesis: Elevated skin temperature will be positively correlated with tissue oxygen Preliminary data suggest skin temperature and tissue oxygen are not correlated; NS What next? Considerations: Need to measure affected areas only? How to find them . . . New technology: ThermoView"! Ti30 thermal imager (Raytek distributor)  displays thermal image and temperature ($10,000) Calibrate and establish validity of thermometers against standards  new and existing thermometers (ASTM, NIST standards) Better understanding of the emissivity of skin Noncontact thermometry Avoids drawdown Conductive heat loss between two objects where heat flows from the warmer to the cooler object (Guiliano 2000; Thomas 1994) Gives an objective measure of a small localized area of skin Many new methods for measuring skin temperature on the horizon: Arthur, R. M.; Kennedy, W. R.; Lanctot, D. R.; Sterzer, F; Tarler, M. D. http://crisp.cit.nih.gov/crisp/CRISP Remember . . . With any new and existing device, need to: ensure frequent calibration establish validity and reliability determine whether a better methods/device exists to evaluate the clinical parameter standardized protocols/procedures for measuring the parameter (reduce measurement error) Remember . . . Measure Tsk under same environmental conditions (home is different than clinic) Need a time and date stamp; need to trend the data It is not a screening mechanism It is not a diagnostic method So . . The purpose of measuring Tsk at this time is to: ESTABLISH INDIVIDUAL BASELINE AND NORMAL VARIABILITY AUGMENT CLINICAL FINDINGS QUANTIFY THE PARAMETER NUMERICALLY TRACK CHANGES OVER TIME Can skin temperature changes guide intervention decisions? Sorry . . . . Not yet! What can we do now to manage signs and symptoms beyond the current standard of care: class 3 compression, leg exercise, elevation and skin care? (evidence reported in Lorimer, K. R., et al. 2003 J WOCN, 30: 132-142.) Pharmacologic management *Micronised purified flavonoid fraction 90% micronised diosmin and 10% flavonoids expressed as hesperidin (Daflon 500 mg, Ardium, Capiven, Elatec, Variton) 500 mg BID (Lyseng-Williams, 2003) Reduced symptoms, ankle and calf swelling, venous emptying time *Horse chestnut seed extract (Aesculus hippocastanum L.) (Venostasin) 600 mg per day (Koch, 2002; Pittler, 2002; Siebert, 2002) Reduced leg volume and ankle and calf circumference Pharmacologic management Pycnogenol (French maritime pine bark extract) 360 mg per day (Koch, 2002) Butchers Broom preparation (Ruscus aculeatus L. Extract) 72 75 mg dry extract) (Vanscheidt, 2002) Total triterpenic fraction of Centella asiatica (TTFCA) (Incandela, 2001) Pharmacologic management Limited evidence Pentoxifylline (Coleridge Smith, 2001) Stanozolol Hydroxyrutosides Nicotine gum/patch (Usuki, 1998) Nitroglycerin Non-pharmacologic interventions Foot pump devices in addition to compression (30 40 mm Hg) 2 hours/day x3 months (Arcelus, 2001) Mind body interventions (Galper, 2003) Thermal biofeedback Pneumatic compression (Berlinger, 2003) Refractory edema with ulcers after 6 months standard therapy Aquatic exercise (Smith, 2003 unpublished dissertation) Accupuncture/electroaccupuncture (Hseih, 2002) effects last up to 3 months Non-pharmacologic interventions TENS high vs. low frequency (Cramp, 2001; 2002) Low frequency reduced edema, symptoms Liquid cooling garments (Hexamer, 1997) Elevation?? need more data to determine optimal leg/body position and compression combinations that prevent severity and maximize healing when an ulcer is present (Wipke-Tevis, 2003 ongoing RO1) Summary Further study is needed to determine the relationship between CVI, clinical and pathological severity, and skin temperature Preliminary data suggest skin temperature is elevated in CVI Preliminary data suggest skin temperature and tissue oxygen are not correlated at one measurement site Summary Currently, there is a place for skin temperature measurement, however, the emerging technology needs to be carefully evaluated for purpose, procedures, and how much emphasis is placed on findings to augment clinical decisions about treatment. 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