Prevention of Hypothermia During Caesarean Section: Forced-air Warming and Continuous Core Temperature Monitoring With Zero-heat-flux
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Hypothermia rate OR
研究概览
简要总结
Nowadays, caesarean sections account for about 7% of all surgical procedures worldwide. Over 30% of the patients undergoing a caesarean section experience a fall of the body core temperature under 36°C during the procedure. Following a retrospective cohort design, this study aims to examine the magnitude of hypothermia in the parturient and newborn population as well as the impact and efficiency of forced-air warming on preventing it. The researchers plan to conduct a retrospective analysis of the caesarean section treatment protocol at our institution over a period of 5 months including approximately 300 patients who underwent both elective and emergency caesarean sections.
详细描述
This research seeks to address the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections. We will also examine the impact of the maternal hypothermia on the newborn temperatures at the time of partus and also 2 hours after birth. The key research question of this study is whether the use of forced-air warming will significantly lower the hypothermia rates and account for a faster temperature recovery in our parturient patients.
A major contribution of our research is that it provides modern high-resolution, continuous and user-error free thermometry. This is achieved through zero-heat-flux technology and automatically recorded by data-loggers. Also, the heterogeneity of our study population, which has not been attended in previous studies, corresponds to the clinical reality of the most obstetric clinics.
This research could provide new information about the necessity of standardizing the use of forced-air warming and monitoring the maternal temperature during caesarean sections, in the concept of bonding the babies to the mother's chest immediately after birth, and derive practical implications on the efficiency of intraoperative warming for the standard clinical routine of the majority of the obstetric clinics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Included will be all Caesarean section deliveries under spinal anaesthesia at our facility in the period from 01.04.2019 to 31.08.2019
排除标准
- •different anaesthesia procedure (e.g. intubation anaesthesia, peridural anaesthesia etc.),
- •American Society of Anesthesiologists (ASA) Classification III or higher,
- •BMI( Body mass index) >45 kg·m-2,
- •patients with incomplete documentation,
- •estimated perioperative blood loss > 500ml,
- •other perioperative complications (ex. insufficient analgesia and change of anaesthesia procedure).
结局指标
主要结局
Hypothermia rate OR
时间窗: Through completion of the surgical procedure, an average of 1 hour
Hypothermia rate in % intraoperatively. The temperature measurements will be started prior to the induction of the anaesthesia and ended when the patient leaves the OR (operating room).
Hypothermia rate RR
时间窗: Through completion of the postoperative recovery, an average of 2 hours
Hypothermia rate in % in the RR (recovery room). The temperature measurements will be started when the patient enters the RR and ended approximately after 2-3 hours when the patient leaves the RR
次要结局
- Delta_recovery(Through completion of the surgical procedure and the postoperative recovery phase , an average of 3 hour)
- Delta_Temp(Through completion of the surgical procedure, an average of 1 hour)
- Delta_Time(Through completion of the surgical procedure, an average of 1 hour)
研究者
Laurentiu Marin, MD
Anaesthesiologist
St. Marien-Hospital Düren