跳至主要内容
临床试验/NCT00913978
NCT00913978终止不适用

A Prospective Randomized Evaluation of Two Perioperative Active Warming Techniques in Maintenance of Normothermia in Colorectal Surgeries

Northwestern University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
50
试验地点
2
主要终点
The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.

研究概览

简要总结

We propose a study in which we compare two intraoperative active warming devices for maintenance of normothermia in patients undergoing colorectal surgery. A novel underbody resistive warming mattress (VitaHeat) will be compared to the forced air warming blanket (3M Bair Hugger) that is currently used in our institution. Our hypothesis is that the underbody resistive warming mattress will be equally effective as forced air warming in maintaining normothermia in colorectal surgery.

详细描述

Stratified randomization will be performed using a computerized randomization table where the strata will be type of surgery (open vs closed) and the treatment will be forced air blanket or underbody mattress warming device. This will allow equal groups of both warming devices in both types of surgery.

Group 1: Patients will receive active warming via a heating mattress (VitaHEAT Medical) placed on the OR table with two thin sheets between the patient and the device; one covering the mattress and the other used as the draw sheet as usual practice. The device will be turned on 10 minutes prior to the patients' arrival to the operating room table. Patients' upper body will be covered with blankets. To increase skin surface contact with the mattress any blankets remaining under the patients' chest or head will be removed after intubation and replaced with a donut.

Group 2: Patients will receive standard forced air warming applied to the upper body and turned on after the patient is prepped and draped. These warmers will be placed directly in contact with the skin without any intervening insulation.

Both groups will have IV fluid warmer initiated on arrival to the operating room. The operating room temperatures will be adjusted to 21°C.

Participation in the study is voluntary. The patients may choose not to enroll in the research. Patients who choose not to enroll will use the standard forced air warmer.

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
Single (Outcomes Assessor)

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

  • •Patients older than 18 years old undergoing laparoscopic or open colorectal surgical procedures under general anesthesia.

排除标准

  • •Any patient who is less than 18 years old.
  • •Emergent surgery
  • •Any patient with thyroid problems
  • •Any patient with preoperative fever
  • •Any patient who is pregnant
  • •Any adult patients unable to consent
  • •Prisoners

研究组 & 干预措施

Group 1: VitaHeat

Active Comparator

Patients in group one will be warmed perioperatively with the VitaHeat mattress and IV fluid warmers once they are in the operating room.

干预措施: Group 1: VitaHeat (Device)

Group 2: Bair Hugger

Active Comparator

Patients in group two will be warmed perioperatively with the upper body bair hugger and IV fluid warmers once they are in the operating room.

干预措施: Group 2: Bair Hugger (Device)

结局指标

主要结局

The Primary Outcome Measure Will be the Percentage of Intraoperative Time the Participants Body Temperature is Above 36 Degrees Celcius.

时间窗: 1 day

The total percent of intraoperative time (time in the operating room) that the body temperature of the participant is above 36 degrees celcius measured using an esophageal temperature probe.

次要结局

  • Post Operative Temperature on Admission to Post Operative Care Unit (PACU)(Immediately after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meltem Yilmaz

Associate Professor in Anesthesiology

Northwestern University

研究点 (2)

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