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临床试验/NCT02837913
NCT02837913终止不适用

Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年6月5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
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

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

Experimental

Underbody warmer will be underneath the patient and turned on.

干预措施: VitaHeat underbody heating mattress (Device)

Underbody warmer off

Placebo Comparator

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

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

Mark Zakowski MD

Principal Investigator

Cedars-Sinai Medical Center

研究点 (2)

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