A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient Perioperative Risk
研究概览
简要总结
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.
In this proposed study researchers will:
- Measure preoperative energy reserve capacity (fitness)
- Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
详细描述
Primary Objective:
• To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters (%predicted AT, %predicted P-VO2, VO2 at AT & peak exercise, oxygen pulse, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy.
Secondary Objectives:
• To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants 18 years of age or older.
- •Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy.
- •Participants who have signed the consent form to participate in the study.
- •Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist.
- •All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center.
- •No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation.
排除标准
- •Participant is under age
- •Participant is unwilling to sign consent.
- •Participant is unable to exercise (bedridden or wheel chair bound).
- •Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.
- •Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
- •Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina.
- •Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation.
- •Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation.
- •Participant is known to have acute or chronic deep vein thrombosis.
- •Participant is pregnant.
研究组 & 干预措施
Cardiopulmonary Exercise Testing (CPET)
干预措施: Cardiopulmonary Exercise Testing (CPET) (Other)
结局指标
主要结局
Patient Perioperative Risk
时间窗: Baseline + 30 days postoperatively monitoring for morbid events
Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk
次要结局
未报告次要终点