Prevalence of Postoperative Hypothermia in Spanish Recovery Units
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Prevalence of Postoperative Hypothermia
研究概览
简要总结
The prevalence of Hypothermia in Spanish Post-Anesthesia Recovery Units (in Spanish: "Prevalencia de Hipotermia en las Reanimaciones Españolas" PHRES Study) is a prospective, multicenter observational study that will evaluate how often adults develop unintended low body temperature after non-cardiac surgery in post-anesthesia recovery units in Spain.
Unintended low body temperature, known as perioperative hypothermia, is a common problem after surgery and may be associated with complications such as shivering, increased bleeding, heart problems, discomfort, and delayed recovery. Although active warming devices and temperature monitoring are available in many Spanish hospitals, their use may vary between centers.
The study will include adults undergoing scheduled non-cardiac surgery lasting more than 60 minutes under general, regional, or combined anesthesia. Approximately 1,334 patients from 25-30 Spanish hospitals are expected to participate.
Patients will be included consecutively according to predefined eligibility criteria. The study will record information about the patient, the type and duration of surgery and anesthesia, and the measures used to prevent low body temperature before and during surgery, including active warming and temperature monitoring.
On arrival in the post-anesthesia recovery unit, the patient's core body temperature will be measured using the same non-invasive temperature monitoring technology in all participating centers. The main objective is to determine the proportion of patients with a core temperature below 36°C at the time of admission to the recovery unit.
The study will also investigate factors associated with postoperative hypothermia and record complications occurring shortly after surgery, such as shivering, hemodynamic instability, new-onset arrhythmias, significant bleeding, and the need for blood transfusion.
This is an observational study. The study will not determine or change how patients are warmed or how their temperature is monitored during surgery. These decisions will remain the responsibility of the treating anesthesia team according to local clinical practice. The additional temperature measurement performed for the study is non-invasive and does not involve any significant additional risk to participants.
详细描述
Background
Unintended perioperative hypothermia, defined as a core body temperature below 36.0°C, is one of the most common complications associated with anesthesia and surgery. During the first hour after induction of anesthesia, the body's normal temperature regulation is impaired, causing heat to redistribute from the core to the peripheral tissues. Additional factors such as exposure to a cool operating room, administration of intravenous fluids, surgical duration, and the extent of the surgical procedure further increase the risk of heat loss.
Postoperative hypothermia has been associated with several adverse outcomes, including shivering, patient discomfort, increased blood loss and transfusion requirements, wound infection, cardiac complications, and prolonged recovery. International guidelines recommend routine temperature monitoring and the use of active warming techniques during surgery. However, the implementation of these recommendations varies considerably between hospitals, and contemporary national data from Spain are not available.
The PHRES Study has been designed to determine the current prevalence of postoperative hypothermia in Spanish post-anesthesia recovery units and to describe perioperative temperature management practices across a wide range of hospitals.
Study Design
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for non-cardiac surgical procedure.
- •Anesthesia duration >60 minutes.
- •General anesthesia, neuraxial anesthesia, or combined general and neuraxial/peripheral nerve block anesthesia.
- •Written informed consent provided by the participant.
排除标准
- •Signs or suspicion of active infection at the time of surgery.
- •Surgical procedure performed under regional anesthesia with sedation only.
- •Cognitive impairment preventing the participant from understanding the study information.
- •Refusal to participate in the study.
结局指标
主要结局
Prevalence of Postoperative Hypothermia
时间窗: At admission to the post-anesthesia care unit, immediately after surgery
Proportion of patients with a core body temperature below 36.0°C at admission to the post-anesthesia care unit (PACU). Core temperature will be measured using a non-invasive zero-heat-flux temperature monitoring system.
次要结局
- Prevalence of Preoperative Active Warming(During the preoperative period, before transfer to the operating room)
- Prevalence of Intraoperative Active Warming(From induction of anesthesia until completion of surgery)
- Prevalence of Intraoperative Core Temperature Monitoring(During surgery)
- Risk Factors Associated With Postoperative Hypothermia(Perioperative/Periprocedural)
- Immediate Postoperative Complications Associated With Hypothermia(Perioperative/Periprocedural)