Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring
Summary
Primary Objective:
The primary objective of the study is to characterize and measure the impact of major surgery on the kinetics of endothelial function during the perioperative period. Reactive hyperemia, characterized by Digital Thermal Monitoring (DTM), will be utilized to characterize this during the perioperative period in patients undergoing major abdominal or thoracic surgery. This will attempt to characterize the relationship between impaired endothelial function, the extent of surgical insult, and the risk for adverse postoperative outcome.
Secondary Objectives:
Secondary objectives of this study will evaluate the following:
- The incidence of major complications in correlation to reduced preoperative reactive hyperemia
- The incidence of major complications in correlation to reduced postoperative reactive hyperemia (calculated as absolute value and as the change from baseline [delta]).
- It is anticipated that two factors (namely, preoperative cardiovascular risk and the extent of the intraoperative inflammatory response) will predominantly contribute to the impaired microcirculatory/hyperemic/endothelial function and should therefore be accounted for in this study. The correlation between impaired reactive hyperemia and these two contributory factors will be evaluated.
1. Preoperative cardiovascular risk will be assessed using risk scoring systems that attempt to infer patient risk according to preoperative co-morbidities, namely The ASA Physical Status Classification System24, The Lee Modified Cardiac Risk Index,25 and The University of Texas M. D. Anderson Cancer Center Modifiers to the Lee Modified Cardiac Risk Index (an unvalidated scoring system that considers factors unique to the cancer surgical population), and The Metabolic Syndrome. The latter represents a larger at-risk patient population who has yet to develop symptomatic cardiac lesions (and therefore will not be identified by the Lee modified Cardiac Risk Index).
2. Intraoperative inflammatory response will be assessed using quantitative assays for C-RP, and cytokines.
- Multivariate analysis will analyze for intraoperative perturbations—including hemodynamic (heart rate, blood pressure), temperature, and fluid shifts (blood loss, transfusions.
Description
The Endothelial Function Test:
To perform an endothelial function test, your temperature will be taken using your fingertip on both hands using the Vendy's-DTM machine. The Vendy's-DTM machine uses small sleeves that fit over your fingertips to take your temperature. After your temperature is taken, your right arm will be placed in a standard blood pressure cuff. After the cuff is inflated for 2 minutes, your temperature will be taken again from the same fingertip. The difference of temperatures before and after inflation may be able to predict endothelial complications, such as lung function, heart failure and heart attack.
This test will be performed within 20 days before your scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after your surgery.
Follow-up:
You will be called to collect information about your overall health at 30 days and 1 year after surgery. The phone call will last about 30 minutes.
Length of Study:
You will be off study after the second phone call.
This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Conditions
Abdominal Surgery
Intervention
Endothelial Function Test
Location
U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030
Status
Active, not recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00683150
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Corneal Endothelial Cell Loss
Loss of CORNEAL ENDOTHELIUM usually following intraocular surgery (e.g., cataract surgery) or due to FUCHS' ENDOTHELIAL DYSTROPHY; ANGLE-CLOSURE GLAUCOMA; IRITIS; or aging.
Abdominal Wound Closure Techniques
Methods to repair breaks in abdominal tissues caused by trauma or to close surgical incisions during abdominal surgery.
Hernia, Abdominal
A protrusion of abdominal structures through the retaining ABDOMINAL WALL. It involves two parts: an opening in the abdominal wall, and a hernia sac consisting of PERITONEUM and abdominal contents. Abdominal hernias include groin hernia (HERNIA, FEMORAL; HERNIA, INGUINAL) and VENTRAL HERNIA.
Rectus Abdominis
A long flat muscle that extends along the whole length of both sides of the abdomen. It flexes the vertebral column, particularly the lumbar portion; it also tenses the anterior abdominal wall and assists in compressing the abdominal contents. It is frequently the site of hematomas. In reconstructive surgery it is often used for the creation of myocutaneous flaps. (From Gray's Anatomy, 30th American ed, p491)
Fibromatosis, Aggressive
A childhood counterpart of abdominal or extra-abdominal desmoid tumors, characterized by firm subcutaneous nodules that grow rapidly in any part of the body but do not metastasize. The adult form of abdominal fibromatosis is FIBROMATOSIS, ABDOMINAL. (Stedman, 25th ed)
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