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
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 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
排除标准
- •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.
研究组 & 干预措施
ALLON System
The ALLON system water garment, is like a large apron that covers your body. There are tubes that run throughout the water garment, which allow warm liquid to flow so that the garment keeps the participant warm. The ALLON system water garment will be filled with warm water.
干预措施: Allon System (Device)
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