Pre-warming With Thermal Gown Prevents Maternal Hypothermia in Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maternal Hypothermia
研究概览
简要总结
Background: Hypothermia is common during general and regional anesthesia even when active warming measures are taken. The existing literature shows that, in pregnant patients, the use of forced air-warming during cesarean section under spinal anesthesia does not prevent maternal hypothermia. Therefore, this study aimed to establish the efficacy of a pre-warming system, initiated 30 minutes before the onset of spinal anesthesia and during surgery, in pregnant women subjected to elective cesarean delivery.
Methods: Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia were allocated to the control group (Gcont, n = 20), without the use of a thermal gown, and to the gown group (Ggown, n = 20), with the use of a thermal gown in the preoperative care unit, 30 minutes before spinal anesthesia installation and during surgery. After the anesthesia, the thermal gown was moved from the regular position and placed over the chest and upper limbs, as an upper body blanket, and maintained throughout the study. The following variables were observed: preoperative and operative room temperature, hemoglobin saturation, heart rate, arterial pressure, tympanic temperature in the preoperative care unit room (baseline) and at 0, 15, 30, 45 and 60 minutes after spinal anesthesia. Repeated Measure ANCOVA compared temperatures of each group, adjusted for baseline values.
详细描述
Introduction Body temperature decreasing following the onset of general or regional anesthesia is caused by a core-to-peripheral redistribution of heat, as demonstrated by several previous studies. Perioperative hypothermia and its complications have been widely studied in patients subjected to non-obstetric surgery; however, literature on the obstetric population is rare, although the incidence of intraoperative shivering can be as high as 60% in these patients. A previous study based on the use of forced air-warming unit during the preoperative and intraoperative periods in patients subjected to cesarean delivery observed a lower incidence of hypothermia and shivering in patients given epidural anesthesia when compared to those given spinal anesthesia.
The forced air system is by far the most commonly used intraoperative warming approach and has an admirable safety record. However, the problem with blanket-forced air warming, circulating-water garments, or water mattresses is that it is impossible to change their position on the bed, which can be uncomfortable, especially if the patient is waiting in a sitting position.
The Bair Paws Gown® presents an air warming system that provides patient-controlled comfort warming in the pre and postoperative setting. The same gown offers effective clinical warming during surgery involving the head, neck, knees or extremities. The air-warming flows through the gown, from knees to head or from head to knees, and allows the patient to be seated with gown covering the area between knees and neck.
Therefore, we designed a study to establish the efficacy of a pre-warming system that keeps the garment throughout the perioperative period, without interruption, initiated 30 minutes before the induction of spinal anesthesia for elective cesarean delivery. The aim of this study was to test the hypothesis that active warming 30 minutes before spinal anesthesia should better prevent a fall in pregnant body temperature. A secondary goal evaluated the incidence of shivering, as well as thermal comfort during the procedure.
Methods After obtaining Institutional Review Board approval (record 388/08) and written informed consent from patients, 40 healthy ASA physical status I or II pregnant women presenting for scheduled cesarean delivery under spinal anesthesia were enrolled in this prospective, randomized study.
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
- 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
- 否
入选标准
- •pregnant women
- •between 18 and 40 years of age
- •singleton pregnancy
- •gestation longer than 37 weeks
- •elective cesarean section
排除标准
- •fever and/or infectious conditions
- •familial history of potential malignant hyperthermia
- •body mass index (BMI) values below 18.5 kg.cm-2 or above 36 kg.cm-2
- •thyroid disorders, dysautonomia, Raynaud's syndrome
- •patient in labor
研究组 & 干预措施
Control
Patients received no active warming before the anesthesia procedure in control groups
Pre-warming
The intervention is to warm patients before the anesthesia procedure in experimental groups
干预措施: pre-warming (Device)
结局指标
主要结局
Maternal Hypothermia
时间窗: 60 minutes
Hypothermia was measured by means of tympanic temperatures.
次要结局
未报告次要终点
研究者
Ricardo Caio Gracco De Bernardis
PhD
Faculdade de Ciências Médicas da Santa Casa de São Paulo
