Clinical Evaluation of the CM-1500 in Postoperative Abdominal and Pelvic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Relative Index Change During PACU Stay
研究概览
简要总结
The primary objective is to evaluate the the changes in the Relative Index in post abdominal or pelvic surgery patients on the Cardiac Monitor Model CM-1500.
详细描述
Postoperative hemorrhage incidence can vary depending on the type of surgery, but it can lead to severe clinical complications ranging from mild anemia to fatal hemorrhagic shock. Monitoring and detecting these fluid changes postoperatively can be complicated, and standard operating procedures vary. The Cardiac Monitor, Model 1500 (CM-1500), uses a personalized approach by non-invasively and simultaneously monitoring five (5) physiological parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent
- •Ability and willingness to comply with study procedures and duration requirements
- •18 years of age or older
- •Undergoing an abdominal or pelvic surgery within the next 10 days
排除标准
- •Females who are pregnant or breastfeeding
- •Participation in other clinical studies involving experimental drugs or devices
- •Undergone an amputation of the left upper extremity
- •Diagnosed with Dextrocardia
- •Subjects who have a Pacemaker
研究组 & 干预措施
Blood Volume Monitoring
干预措施: CM-1500 (Device)
结局指标
主要结局
Relative Index Change During PACU Stay
时间窗: Length of PACU Stay (Range: 46 to 353 minutes)
The primary objective is to evaluate changes in the Relative Index (RI) in post-abdominal or pelvic surgery patients (Laparoscopic or Open). The CM-1500 monitors parameters which are indicative of relative changes in fluid volume in adult patients. The Relative Index is an investigational value which utilizes proprietary algorithms to combine the relative changes of each measured parameter into a single value. The Relative Index is graded on a scale where 100 indicates a patient's baseline, and changes up or down from the baseline could be used as potential indicators of fluid gain or loss relative to the baseline, based on the changes of the individually monitored parameters. Per the device's FDA 510(k) clearance, the RI is computed as the weighted summation of the percent change values (signifying the deviation of each parameter from it's baseline value) for its parameters. Change in RI is calculated by subtracting the initial RI value from the final RI value during monitoring.
次要结局
未报告次要终点