Diabetes Mellitus Type II and Tissue Oxygenation
The purpose of this study is to determine whether diabetics have decreased amounts of oxygen in the skin compared to non-diabetic individuals, and if the amount of oxygen in the skin changes when given more oxygen to breathe around the time of surgery. To do this, the investigators will be measuring the amount of oxygen in the skin of diabetic and non-diabetic individuals who will be undergoing abdominal surgery lasting 2-4 hours. These measurements will be taken at three different times.
Diabetes Mellitus, Type II
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period|
|Study Start Date:||November 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
The goal is to test the hypothesis that: 1) perioperative subcutaneous oxygenation (PsqO2) is lower in diabetic than non-diabetic patients; and, 2) supplemental oxygen provides less benefit in diabetic than non-diabetic patients.
We propose a prospective case-control study which will include 30 Type II diabetics matched for age, sex, and race to 30 non-diabetic controls. Patients will be preselected from a population undergoing abdominal surgery and given supplemental inspired oxygen of 30 - 80% to PaO2 of approximately 150mmHg and/or 300mmHg at three timpoints in the perioperative period. PsqO2 will be measured with an IV-sized probe inserted through a small incision made in the skin. Data will be recorded and analyzed using unpaired two tailed t-test, Wilcoxon's ranked sum test, or repeated-measures analysis of variance (ANOVA) test as appropriate.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554697
|Study Chair:||Daniel I Sessler, M.D.||The Cleveland Clinic|
|Principal Investigator:||Andrea Kurz, M.D.||The Cleveland Clinic|