Development & Validation of Preoperative Objective Physiological Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total amount of oxygen consumed per minute
研究概览
简要总结
This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.
详细描述
All surgical patients presenting at the Preoperative Anesthesia & Surgical Screening (PASS Clinic) will complete the Duke Activity Status Index (DASI) self-reported questionnaire as standard of care. If the DASI score is 34 or greater, the patients will not be considered for the study. If the DASI score is 33 or lower, the patient will be considered as a potential study participant. Eligible study participants will then complete a sub-maximal exercise test (Six Minute Step Test, 6MST) with measured VO2.
The VO2 is an integral part of preoperative assessment of cardiorespiratory fitness (CRF). A low CRF is associated with a higher incidence of post-operative complications and mortality. The study will evaluate the ability to estimate VO2 from exercise-derived measurement with questionnaire-derived estimation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Able to speak English
- •Ambulatory [assistive devices ok]
- •Preoperative Anesthesia and Surgical Screening (PASS) clinic patient with DASI score <34
- •Able to provide informed consent
排除标准
- •Acute myocardial infarction (3-5 days)
- •Unstable angina
- •Severe untreated arterial hypertension at rest (>200 mm Hg systolic, >120 mm Hg diastolic)
- •Resting heart rate > 120 bpm
- •Room air desaturation at rest on room air <85%
- •Inmate of correctional facility (i.e. prisoner)
- •Diagnosed history of dementia
- •Inability to ambulate independently
- •Considered inappropriate to participate by Principal Investigator
研究组 & 干预措施
6MST VO2
Completion of 6MST exercise protocol
干预措施: Exercise (Behavioral)
DASI VO2
Completion of DASI fitness activity questionnaire
干预措施: Exercise (Behavioral)
结局指标
主要结局
Total amount of oxygen consumed per minute
时间窗: Up to 15 minutes
Oxygen consumption measured in mL/min
次要结局
未报告次要终点