Prospective Observational Study on the Incidence of Perioperative Hypothermia and the Effect of Standard Normothermia Measures at the Surgical Area of Parc Tauli Hospital Universitari, Sabadell: Tauli-Previnq-Warm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Rate of perioperative hypothermia (<36ºC)
研究概览
简要总结
The study TAULÍ-PREVINQ-WARM will assess the rate of perioperative hypothermia in patients submitted to major surgical procedures at the operating room main area (and at the ambulatory surgery building for ophthalmologic major procedures) of the Parc Taulí, Hospital Universitari, Sabadell, Barcelona.
详细描述
Treatment plan The month before the start of the study, investigators will double check with the administrative personnel the potential candidates to be included in to the study. Furthermore, investigators will meet with the responsible of each surgical specialty to delineate the adequate staff workload and collaborators needs. To assure the best study performance and to avoid selection patient bias, patients will be consecutively included in blocs of each designated surgical specialty.
At the patient admission area and surgical preparation, associated investigators will inform to candidates and relatives about the project giving the informed form to be signed.
Patient inclusion will include a pilot phase (four to five patients) to teach collaborators regarding the correct placement of cutaneous sensor, data lecture and registration to the database. Along with the maintenance department of the hospital, we also assess the correct installation and function of temperature and humidity sensors at the OR (Mini-datalogger 174H, Instrumentos Testo, S.A. Cabrils, Barcelona). OR temperature and the degree of humidity will be measured at the specific time points stated at the paragraph of the measurements.
Body temperature (BT) measurements will be performed at the UPQ, anesthesia preparation room, OR and URPA in those specifically stated time points (Annex 2 and Figure 1).
Because the investigators want to perform a pragmatic study, patients will receive conventional normothermia preventive measures following the approved local guidelines from the Anesthesiology Department.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA score I to IV
- •Patients submitted to major surgical procedures at the main OR facilities (or at the ambulatory surgery building for ophthalmologic procedures) under general or neuraxial anesthesia from surgical specialties
- •Patients (parents or legal guardians regarding pediatric patients) that have signed informed consent form.
排除标准
- •Patients submitted to craniofacial neurosurgical procedures
- •Patients submitted to any surgical procedure requiring draping or sterile isolation of the frontal part of head, precluding intraoperative assessment of SpotOn sensor.
- •Patients (parents or legal guardians regarding pediatric patients) that have not signed informed consent form.
- •Patients that by the time of the hospital admission present a relevant inflammatory or infectious process at the skin of frontal part of the head
- •Patients diagnosed with psychiatric disease relevant enough to avoid adequate staff-patients communication for this specific study
结局指标
主要结局
Rate of perioperative hypothermia (<36ºC)
时间窗: 12 hours
Body temperature measured by SpotOn system sensor in different surgical procedures and at any specific surgical area.
次要结局
- Temperature at the operating room(1-6 hours)
- Adverse events(Up to 30 days (1 year for prosthetic surgery))
- Type and duration of applied physical measures to prevent periopertive hypothermia(12 hours)
- Thermal confort(1-6 hours)
研究者
Xavier Guirao
Coordinator of Endocrine, Head and Neck Surgery Unit
Corporacion Parc Tauli