Study Using Fluid Warming and Forced Air Warming Immediately Prior to and During Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- temperature
研究概览
简要总结
During surgery body temperature can decrease which can adversely affect how people recover from surgery. This is a common problem. We aim to reduce the incidence of this drop in body temperature during surgery by testing the effectiveness of warm intravenous fluids that the patients will receive as they are being infused, and of warm air blown into a blanket covering the body. The control group will not have any active warming methods.
Study group 1 will have the intravenous fluid warmer in the pre- and intraoperative period. Study group 2 will have a forced-air warmer in the intra-operative period as well as the fluid warmer in the pre- and intraoperative period. We will also observe the neonates' vital signs following delivery.
详细描述
Potential participants will be approached by a member of the research team prior to surgery.
Patients will be fully informed of the study by a study investigator, full written informed consent will be obtained. We will recruit healthy ASA 1 and 2 patients undergoing uncomplicated elective cesarean sections. Patients will be randomised into one of three groups.
Control group will have no active warming. Study group 1 will have pre- and intraoperative intravenous fluid warming. Study group 2 will have the same as study group 1 but with additional intraoperative warming air blown into a blanket covering the body.
Temperature measurements will be taken in the pre-op holding area prior to intravenous fluid administration, and thereafter at 15-minute intervals until one hour post-surgery.
At the same time as temperature monitoring the patients will be assessed for shivering (4 point scale) and will be asked their comfort level with regard to their temperature (5 point scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-40 years. Healthy term (> 37 weeks) pregnant patients undergoing elective cesarean section with spinal anesthesia.
- •We will not discriminate with regard to ethnic background. ASA 1 and 2 patients scheduled for elective cesarean sections under spinal anesthesia at LPCH.
排除标准
- •Not ASA 1 or 2 Not spinal anesthetic
研究组 & 干预措施
Warmed fluids and warm air
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
干预措施: Fluid warmer and warming blanket (Other)
Control
No peri-operative warming.
Warmed fluids
Patients will receive warmed i.v. fluids administered pre- and intra-operatively.
干预措施: Warmed fluids (Other)
Warmed fluids
Patients will receive warmed i.v. fluids administered pre- and intra-operatively.
干预措施: Belmont fluid warmer (Device)
Warmed fluids and warm air
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
干预措施: Warmed fluids (Other)
Warmed fluids and warm air
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
干预措施: Belmont fluid warmer (Device)
Warmed fluids and warm air
Patients will receive warmed i.v. fluids administered pre- and intra-operatively, and warmed air blown into a blanket covering the body intra-operatively.
干预措施: Bair hugger warming blanket (Device)
结局指标
主要结局
temperature
时间窗: immediately prior to surgery upto 3hours post spinal anesthetic
measured every 15 minutes from spinal anesthetic administration
次要结局
- Fetal pH(Post partum)
研究者
Edward Riley
Principle Investigator
Stanford University