Diabetes Mellitus Type II and Tissue Oxygenation
Influence of Diabetes Mellitus Type II on Tissue Oxygenation in the Perioperative Period
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
We will include 30 patients who have more than a five-year history of insulin-dependent type-2 diabetes mellitus and 30 non-diabetic patients meeting the following criteria:
- 35 - 65 yrs old
- BMI < 30
- ASA class I - III
- Abdominal surgery scheduled to last between 2- 4 hours
For Non-diabetic group:
previous BMP within the last year demonstrating glucose < 126mg/dL
For Diabetic group:
- DMII defined as fasting plasma glucose of > 126 mg/dL at time of diagnosis, now requiring insulin
- At least one diabetes associated vasculopathy: coronary artery disease, diabetic nephropathy, hypertension, diabetic retinopathy, diffuse neuropathy, peripheral vascular disease, or a history of stroke
Exclusion Criteria:
- Pregnant
- 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].
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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1
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2
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Diabetes Mellitus Type II and Tissue Oxygenation
時間枠:5 years
|
5 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Andrea Kurz, M.D.、The Cleveland Clinic
研究記録日
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最終確認日
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