Randomized, Prospective Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Perioperative Surgical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Duration of hypothermia
研究概览
简要总结
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.
Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:
- Increased comfort in the pre-operative period by being warmer
- Decreased incidence of mild hypothermia
- Possible decreased incidence of transfusion with less bleeding
- Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
- Possible shorter stay in the PACU and overall Length of Stay (LOS)
- Possible decreased risk for surgical site infection
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective or "urgent" surgery under general anesthesia
- •≥19 years but ≤85 years of age
- •Able to provide informed consent.
排除标准
- •Refusal of Informed consent
- •Metabolic derangement/drug therapy already affecting thermal homeostasis
- •Preexisting hypothermia (<35.5 degreeC) or hyperthermia (>37.5 degreeC) (oral)
- •Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
- •Emergency (category 1a) Surgery
- •Patients undergoing exclusively spinal or epidural anesthesia
- •Patients receiving aortic cross-clamping
- •Patients receiving transdermal medications
研究组 & 干预措施
Bair PawsPatient Adjustable Warming System
Bair PawsPatient Adjustable Warming System for active pre-warming
干预措施: Bair Paws Patient Adjustable Warming System (Device)
Passive pre-warming
Passive pre-warming
干预措施: Bair Paws Patient Adjustable Warming System (Device)
结局指标
主要结局
Duration of hypothermia
时间窗: Up to 12 hours, until PACU discharge
The primary endpoint is duration of hypothermia as measured by the area under the curve (AUC). This is achieved by recording patient temperature readings continuously from baseline (prior to initiation of 30 minutes if active or passive pre-warming) until PACU discharge.
次要结局
未报告次要终点