Peri-Operative Forced Air Warming During Elective Cesarean Section Under Spinal Anesthesia Prevent Maternal and Fetal Hypothermia?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of maternal hypothermia (<36°C)
研究概览
简要总结
Intraoperative hypothermia is common during cesarean delivery under spinal anesthesia and contributes to maternal discomfort, shivering, and metabolic stress. Active warming systems such as forced-air warming are recommended in perioperative guidelines; however, their effectiveness in obstetric anesthesia remains variably documented.
This randomized controlled trial evaluated whether perioperative forced-air warming reduces maternal hypothermia and shivering during elective cesarean section under spinal anesthesia without adversely affecting neonatal outcomes.
详细描述
Spinal anesthesia impairs thermoregulation by inhibiting vasoconstriction and redistributing core heat to peripheral compartments. As a result, parturients undergoing cesarean delivery are at increased risk of peri-operative hypothermia (<36°C). Even mild hypothermia is associated with shivering, increased oxygen consumption, and maternal discomfort.
This prospective randomized controlled trial compared preoperative forced-air warming with standard thermal care in term parturients undergoing elective cesarean delivery under spinal anesthesia.
The study was conducted between June 2023 and December 2025. A total of 120 participants were enrolled and randomized equally into two groups. Maternal core temperature trends, incidence of hypothermia, shivering, thermal comfort, and neonatal outcomes were analyzed.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors were blinded to treatment allocation. Participants, care providers, and investigators were aware of the assigned intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Age ≥18 years
- •Term pregnancy (≥37 weeks' gestation)
- •Scheduled elective cesarean delivery
- •ASA physical status I-II
- •Undergoing spinal anesthesia
- •Provided written informed consent
排除标准
- •• Emergency cesarean section
- •Preoperative fever (>38°C) or hypothermia
- •Thyroid or significant metabolic disorders
- •Known intrauterine infection
- •Contraindication to spinal anesthesia
- •Refusal to participate
研究组 & 干预措施
Perioperative Forced-Air Warming
Participants received perioperative forced-air warming during elective cesarean delivery under spinal anesthesia in addition to standard perioperative care.
干预措施: Forced-Air Warming (Device)
Standard Care
Participants received standard perioperative care without forced-air warming during elective cesarean delivery under spinal anesthesia.
结局指标
主要结局
Incidence of maternal hypothermia (<36°C)
时间窗: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).
Maternal hypothermia is defined as a core body temperature \<36.0°C measured intraoperatively and in the immediate postoperative period.
Incidence of Maternal Hypothermia
时间窗: From induction of spinal anesthesia until discharge from the post-anesthesia care unit (approximately 3 hours).
Maternal hypothermia is defined as a core body temperature of \<36.0°C measured intraoperatively and in the immediate postoperative period.
次要结局
- Maternal Shivering Score(This period extends from the preoperative phase through surgery and into the first hour in the post-anesthesia care unit (PACU).)
研究者
Dr. Eynas Omer Ibrahim Abdalla
Consultant Anesthesiology
Hamad Medical Corporation