NCT01626690终止4 期
Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
研究概览
简要总结
The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing total hip arthroplasty under neuraxial anesthesia,
- •age 55-85,
- •BMI 18-40
排除标准
- •allergy to local anesthetics,
- •patients electing to have general anesthesia for their total hip arthroplasty,
- •pregnancy,
- •prisoners,
- •patients unable to give informed consent,
- •English as a second language,
- •active infectious or febrile illness (measured temperature > 37.5 degrees Celsius).
研究组 & 干预措施
Pre-Warming
Experimental
干预措施: Bair-Paws Warming Device (Device)
Control
Active Comparator
干预措施: Bair-Hugger Warming Device (Device)
结局指标
主要结局
Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
时间窗: The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
次要结局
- Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Intraoperative Blood Loss.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Incidence of Perioperative Cardiac Events.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Temporal Artery Verus SpotOn (3M) Temperature Readings.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Incidence of Postoperative Shivering in Recovery Room.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
- Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.(The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).)
研究者
研究点 (1)
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