Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Inadvertent Hypothermia Prevention
研究概览
简要总结
The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery.
详细描述
Maintaining patient's body temperature is of major importance in patients undergoing surgical procedures and existing methods to warm patients to maintain perioperative normothermia have limitations. This results in as many as half of patients undergoing surgery developing inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to a patient. The EnsoETM potentially improves the ability to control patient temperature by eliminating the disadvantages of existing methods while maintaining the functionality of the orogastric tube that it replaces.
The primary objective of this study is to measure the number of degree-hours spent below 37°C intraoperatively and until recovery in the PACU. This measure will be compared between patients having standard management of body temperature to patients having the EnsoETM placed as an additional warming device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Provision of signed and dated informed consent form
- •Male or female, ages 18 years and older
- •Scheduled for major surgical procedures requiring general anesthesia and with no known contraindication to having an orogastric tube placed for the duration of the surgery
- •The time in the OR is expected to last at least 180 minutes
排除标准
- •Esophageal strictures (risk of perforation)
- •Patients with known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia, etc.)
- •Known ingestion of acidic or caustic poisons within the prior 24 hours.
- •Patients with <40 kg of body mass
- •Coagulopathy
- •Severe facial trauma
- •Surgical procedures lasting less than 3 hours
结局指标
主要结局
Inadvertent Hypothermia Prevention
时间窗: Time from intubation until extubation, approximately 3-12 hours
Number of degree-hours spent below 37 °C intraoperatively until recovery in the PACU and return to 37°C body temperature.
次要结局
- Time From Intubation Until Extubation(perioperative, approximately 3-12 hours)