Diabetes Mellitus Type II and Tissue Oxygenation
|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|
- Diabetes Mellitus Type II and Tissue Oxygenation [ Time Frame: 5 years ]
|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 timepoints 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|