Effect of Active Warming Prior to Surgery in Perioperative Hypothermia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 2
- 主要终点
- Perioperative hypothermia
研究概览
简要总结
This study evaluates the effect of active prewarming on the frequency and duration of perioperative hypothermia. 50% of patients will receive active warming with forced-air devices prior to entering the operating room, and the other 50% will not receive any active heating measures.
详细描述
Inadvertent perioperative hypothermia is defined as a body temperature below 36º C during the perioperative period. It occurs as a result of the effects of anesthetic drugs on the regulation of body temperature and exposure to a cold environment.
The main temperature loss during the perioperative period occurs during the first hour after the anesthetic induction as a result of heat redistribution from the central compartment to the peripheral compartment
The most effective strategy to prevent perioperative hypothermia is the use of forced-air warming devices. These devices are usually initiated once the patient enters the operating room. At that time, the patient has already initiated the heat loss by distributing heat from the central to the peripheral compartment to maintain body temperature.
We intend to use forced-air warming devices before the patients is transferred to the operating room in order to preserve the peripheral body temperature. This way the redistribution of heat should be avoided and, therefore, perioperative hypothermia and its harmful effects will be prevented.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years old.
- •American Society of Anesthesiologists I-III.
- •Undergoing surgery under general or locoregional anesthesia lasting more than 30 minutes.
- •General surgery: hernias, cholecystectomies, hepatectomies, intestinal resections, pancreatoduodenectomies ...
- •Traumatology and orthopedics: total / partial knee prosthesis, total / partial hip prosthesis, osteosynthesis, removal of material, arthroscopies, hallux valgus, lumbar arthrodesis ...
- •Neurosurgery: lumbar arthrodesis, excision of intracranial tumors.
- •Gynecology: Hysterectomies, adnexectomies, hysteroscopy ...
- •Otorhinolaryngology: septoplasty, nasosinusal endoscopic surgery, tonsillectomies, adenoidectomies, thyroidectomies...
- •Thoracic: Pneumonectomies and pulmonary resections, sympathectomies, thoracoscopy ...
- •Urology: Bladder transurethral resection , prostate transurethral resection, nephrectomies.
- •Maxillofacial: parathyroidectomies, microsurgery ...
- •Ability to understand the study, give authorization and collaborate with data collection
排除标准
- •Local anesthesia or peripheral nerve block.
- •Urgent or emergent surgery.
- •Cognitive impairment or lack of collaboration of any kind
- •Pregnant women undergoing cesarean section.
- •Diabetes Mellitus poorly controlled (HbA1c> 6.5-7%)
- •Subjects that are under treatment with drugs that interfere with thermoregulation or may cause drug-induced hyperthermia (amphetamines, barbiturates, inhaled gases ...)
- •Subjects with burns, pressure ulcers and other surface disturbances that cover the heating devices
- •Subjects with screening temperature > 37.5º C.
- •Subjects with fever or active infections.
- •Subjects with chronic anemia who require periodic transfusions
结局指标
主要结局
Perioperative hypothermia
时间窗: From 1 hour to 12 hours
Core temperature below 36º C measured with 3M Spot On monitor every 5 minutes from arrival to the pre-surgical area, during surgery and unit discharge to the ward
次要结局
- Hospital stay(From date of Admission in hospital until the date of discharge from hospital, assessed up to 120 days.)
- Hypothermia duration(Minutes with core temperature below 36ºC from arrival to the OR unit discharge to postoperative unit, up to 10 hours, whichever came first.)
- Surgical site infection(1 Month)
- Prewarming duration(From 10 minutes to 1 hour)
研究者
RECIO PÉREZ, JESÚS
ANESTHESIOLOGIST
University of Alcala