Verification of Clinical Utility: enFlow IV Fluid and Blood Warming System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maintenance of intraoperative core temperature
研究概览
简要总结
This study is part of a post-market clinical follow-up (PMCF). The purpose of this study is to verify in a routine clinical environment with a number of caregivers and subjects that the enFlow performs as intended when used as an element of maintaining acceptable core temperatures.
详细描述
Eligible subjects from the study will be recruited from patients with scheduled surgeries. After being informed about the study and potential risks, patients given informed consent will undergo scheduled surgery with the use of enFlow IV Fluid and Blood Warming System. The following temperature measurements will be collected during surgery:
- Baseline temperature measurement (0-15 minutes prior to induction)
- Induction temperature measurements (15 minutes, 30 minutes, 60 minutes, 90 minute post-induction)
- Continued temperature measurements (every 30 minutes, plus end of surgery)
- OR ambient temperature at induction and end of surgery.
Temperature will be measured and collected post-surgery upon arrival to the PACU and 30 minutes post-arrival.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •18 years of age or older
- •Patients requiring surgery expected to last at least 1 hour.
- •Expectation of the perioperative need for at least one liter of infused fluids warmed during infusion
- •Informed Consent
排除标准
- •Recent history of fever (>38 C, within 24 hours of surgery)
- •Active infection
- •Pregnant women
- •Terminal illness (<30 days)
- •Intended use of cardiopulmonary bypass
- •Clinical intention for perioperative cooling and hypothermia
- •unavailability of esophageal measurement during surgery
- •Attending physician does not believe participation of the patient is in their best interest.
结局指标
主要结局
Maintenance of intraoperative core temperature
时间窗: 15 and 30 minutes post-induction, then every 30 minutes untl the termination of the scheduled surgical procedure, and a final measurement recorded at the time of termination of the scheduled surgical procedure.
Core temperature is defined as the highest temperature reading during 30 seconds made within 5 minutes of protocol time. The primary outcome measure will be the mean of the temperature measurements taken during the course of surgery
次要结局
- Core temperature for two periods(Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,)
- Number of hypothermic events(During 30 seconds made within 5 minutes of protocol time)
- Number of hyperthermic events(During 30 seconds made within 5 minutes of protocol time)
- Incidence of infusate outside acceptable operating range (i.e., device "green range")(Induction: first 90 minutes. Post-Induction: after 90 minutes until the end of surgery,)