Thoracic Surgery Clinical Trial
Official title:
Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function
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.
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.
;
Observational Model: Case-Only, Time Perspective: Prospective
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