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Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function


N/A
18 Years
N/A
Not Enrolling
Both
Abdominal Surgery, Thoracic Surgery

Thank you

Trial Information

Characterizing the Perioperative Kinetics of Reactive Hyperemia Using Noninvasive Digital Thermal Monitoring: an Observational Study of a Surrogate Marker of Endothelial Function


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.


Inclusion Criteria:



1. Male and female patients 18 years and older

2. Patient scheduled for major abdominal (intraperitoneal) or thoracic (intrapleural)
surgery

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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome 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

Safety Issue:

No

Principal Investigator

Vijaya Gottumukkala, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2008-0126

NCT ID:

NCT00683150

Start Date:

May 2008

Completion Date:

November 2010

Related Keywords:

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

Name

Location

UT MD Anderson Cancer Center Houston, Texas  77030