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CompletedNCT00683150Updated Jul 31, 2012

Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring

An observational study in Abdominal Surgery and Thoracic Surgery, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-31.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
59
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed 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.

02

Conditions studied

  • Abdominal Surgery
  • Thoracic Surgery

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Keywords

  • Endothelial Function
  • Abdominal Surgery
  • Thoracic Surgery
  • Vendy's-DTM Machine
  • Digital Thermal Monitoring
  • DTM
03

In context

Hyperemia

85 studies on the registry are indexed under Hyperemia; 37 are open to participants now.

This study's enrollment of 59 is below the median of 85 across 40 observational studies indexed under Hyperemia.

Browse Hyperemia studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study participants scheduled to have major abdominal or thoracic surgery.

Inclusion criteria

  1. Male and female patients 18 years and older
  2. Patient scheduled for major abdominal (intraperitoneal) or thoracic (intrapleural) surgery

Exclusion criteria

Exclusion Criteria:

  1. Patients under age of 18. They will be excluded because it is less likely for this patient population to face endothelial dysfunction secondary to vascular sclerosis.
  2. Patients unwilling to sign an informed consent.
  3. Any patient whose condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
  4. Patients with lymphedema in the arm.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
59 participants (actual)

Groups and cohorts

  • Endothelial Function Test

    Patients scheduled to have major abdominal or thoracic surgery.

    Other: Endothelial Function Test

Interventions

  • OtherEndothelial Function Test

    Endothelial function tests performed within 20 days before surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery.

06

What researchers measure

Primary outcomes

  1. Ratio of each post baseline temperature rebound (TR) measure to baseline

    Time frame: Tests performed within 20 days before scheduled surgery, when surgery begins (at the time of incision), every hour during surgery and then 1, 2, 3, and 5 days after surgery

07

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00683150
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
May 23, 2008
Start date
May 2008
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Jul 31, 2012

Study contacts

Vijaya Gottumukkala, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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