Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 主要终点
- Diabetes Mellitus Type II and Tissue Oxygenation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Immunocompromised: HIV/AIDS, on immunosuppressant therapy for any reason, or post-organ transplantation.
- •Infection or fever, or on glucocorticoids
- •Malignancy currently requiring radiation or chemotherapy
- •Liver or renal failure
- •Pancreatic insufficiency, dysautonomia, thyroid disease, Raynaud's syndrome, pathologic Allen-test, or any coagulopathies
- •Respiratory disease affecting ability to reach PaO2 of 300mmHg: COPD, emphysema, cystic fibrosis, asthma, pneumonia, PE
- •Smoker within the past 6 months or current alcohol abuse
- •Allergy to local anesthetic
- •For diabetics: DMI, other specific subtype, and gestational diabetics
- •We will also exclude patients with epidural catheter, to avoid the influence of regional anesthesia on tissue oxygenation [37, 38].
结局指标
主要结局
Diabetes Mellitus Type II and Tissue Oxygenation
时间窗: 5 years
次要结局
未报告次要终点
研究者
Andrea Kurz
Principal Investigator
The Cleveland Clinic