Use of Water Warming/Cooling Garment to Maintain a Constant Intraoperative Core Target Temperature in Patients Undergoing Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Proof-of-Concept Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer.
研究概览
简要总结
To look at the feasibility of using a water warming/cooling garment (called the ALLON system) to maintain a target body temperature during surgery and chemotherapy perfusion (a method of pouring chemotherapy throughout your abdominal cavity) without overheating or overcooling your body.
详细描述
Objectives:
Primary Objectives:
To evaluate the feasibility of using a water warming/cooling garment (Allon system) to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core (esophageal) hyperthermia (≥39.5°C).
Secondary Objective:
To evaluate the safety for all study participants when using of the Allon system strategy in achieving and maintaining a bladder temperature of ≥38°C for at least 30 minutes or longer during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy while avoiding core hyperthermia (≥39°C)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Adults patients (>18 years old)
- •Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy with an expected duration of perfusion longer than 60 minutes
- •Signed informed consent
- •Exclusion criteria:
- •America Society of Anesthesiology (ASA)physical status >4
- •Patient undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for recurrent disease.
- •Patients with open wounds
- •Patients with a history of thermoregulatory diseases such as spinal cord injury, thyroid disease, and malignant hyperthermia.
排除标准
- 未提供
结局指标
主要结局
Number of Patients to achieve and maintain a bladder temperature of ≥38°C for at least 30 minutes or longer.
时间窗: through HIPEC surgery (up to 4 hours)
次要结局
未报告次要终点