Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Temperature
研究概览
简要总结
The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated.
Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •will be age >18 years,
- •singleton pregnancy >37 weeks,
- •neuraxial anesthesia,
- •healthy afebrile patients.
排除标准
- •• will be age >18 years,
- •singleton pregnancy >37 weeks,
- •neuraxial anesthesia,
- •healthy afebrile patients.
研究组 & 干预措施
Underbody warmer on
Underbody warmer will be underneath the patient and turned on.
干预措施: VitaHeat underbody heating mattress (Device)
Underbody warmer off
Underbody warmer will be underneath the patient but not turned on.
干预措施: VitaHeat underbody heating mattress (Device)
结局指标
主要结局
Temperature
时间窗: 15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit
Temperature at time of post anesthesia care unit admission
次要结局
- Number of Participants With Shivering(15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit)
- Vitals: Heart Rate(Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals)
- Blood Loss(Documented at the end of 2 hour surgical procedure)
- Time to Neonatal Bonding(time from delivery to first maternal contact during the 2 hour surgical procedure)
- Thermal Comfort Visual Analog Scale(Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals)
- Vitals: Oxygen Saturation(Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals)
- Vitals: Blood Pressure(Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals)
研究者
Mark Zakowski MD
Principal Investigator
Cedars-Sinai Medical Center
