Randomized Evaluation of Arterial Pressure Based Cardiac Output for Goal-Directed Perioperative Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Length of Hospital Stay (LOS) by Participant
研究概览
简要总结
The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields comparable patient outcome as fluid administration optimization using a global standard care method.
详细描述
THE EDWARDS VIGILEO MONITOR:
The Vigileo™ monitor measures the amount of blood the heart pumps through the body.
SCREENING TEST:
Before you can begin this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Women who are able to have children must have a negative urine pregnancy test.
STUDY GROUP:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient is in hospital for study indicated treatment.
- •Patient is able to comply with the study procedure.
- •Patient must require an indwelling radial or a femoral artery catheter.
- •Patients with an American Society of Anesthesiologists Risk Score >=
- •Lee Risk Index >/= 2 (Hypertension and Pre-diabetic metabolic state).
- •Patient must be 40 kg or heavier.
- •Patient has consented to be in the trial.
- •Patient's height and weight can be accurately obtained prior to study start.
- •Patient's ability to undergo major surgery with an anticipated blood loss > 500 ml.
排除标准
- •Patients with contraindications for the placement of radial, femoral, or other arterial cannula.
- •Patients with contraindications for the placement of central venous cannula.
- •Patients being treated with an intra-aortic balloon pump.
- •Patients with aortic valve regurgitation.
- •Patients with atrial fibrillation.
- •Female patients with a known pregnancy confirmed by urine pregnancy test.
- •Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
结局指标
主要结局
Length of Hospital Stay (LOS) by Participant
时间窗: From baseline (first day of hospital stay) to release from hospital (anticipate 5 days minimally)
Length of hospital stay of arterial pressure-based cardiac output (APCO) monitor participants versus the participants using the global standard care guided by esophageal Doppler, measured in days.
次要结局
未报告次要终点