Impact of Optimal Temperature Control in Body Contouring Surgery: A Non-Randomized Controlled Clinical Trial
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
- Chills
研究概览
简要总结
The goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other Aesthetic Plastic Surgery procedures. The main question(s) it aims to answer are:
- Do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures?
- Does an active normothermia prevention protocol have any impact in the clinical setting?
Four different protocols will be used for patient peroperative preparation for normothermia.
详细描述
Participants will receive either of four different protocols for normothermia: Group 1 (Control) involved patients with standard temperature management according to regular institutional protocol, without preoperative or intraoperative thermal protection measures. Group 2 (Passive thermal protection measures) had patients who underwent one-hour preoperative warming with hot air at 38°C (100.4°F), the operating room (OR) temperature was maintained at a minimum of 21°C (69.8°F), aseptic/antiseptic solutions along with infiltration fluid were all warmed to 38°C (100.4°F), and surgical fields were kept as dry as possible. In Group 3 (Active thermal protection measures), patients received the same measures as Group 2, adding continuous intraoperative temperature protection, using a thermal convection blanket by water flow (Blanketrol®) at 40°C (104°F). Group 4 (active thermal protection measures) included patients with the same measures as Group 2, adding permanent intraoperative thermal protection measures with conductive fabric electric warming device (HotDog®) at 40°C (104°F).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy.
- •Healthy patients without underlying comorbidities (classified as ASA≤II)
排除标准
- •Women with BMI >30 kg/m²
- •men with BMI >32 kg/m²
- •Patients after massive weight loss
结局指标
主要结局
Chills
时间窗: Immediately at awakening at the recovery room.
Yes or NO
Pain intensity
时间窗: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.
Visual analogue scale rating
Shivering
时间窗: Immediately at awakening at the recovery room.
Yes or NO
Recovery Period
时间窗: Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.
Time from Operating Room to discharge from the recovery room.
Analgesic requirements
时间窗: Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.
Measure the amount of analgesic required for pain control
Hypothermia prevention
时间窗: Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.
Measure the body temperature throughout the procedure
次要结局
- Cost-effectiveness of each intervention(Throughout the study completion, about 1 week.)
研究者
Alfredo Hoyos
Chief of Department of Plastic Surgery
Total Definer Research Group