A Study To Determine Whether Carbon Polymer Blankets Can Reduce The During And After Short, Day Operations
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Core temperature
研究概览
简要总结
Patients whose temperature drops below 36.0 degrees Centigrade during or after surgery suffer more complications, such as wound infections and increased blood loss, resulting in more blood transfusions and longer hospital stays than those who don't.
There is evidence that even a drop below 36.5 degrees Centigrade is sufficient to cause significant adverse effects. Although there is much evidence regarding the effectiveness of warming for long operations, there is nothing looking at short procedures such as those undertaken in the daysurgery setting.
A new carbon polymer blanket (HotDog Augustine Biomedical and Design) has been shown, in volunteer studies, to be as effective as forced air warming blankets (which are used for long operations) in preventing hypothermia. In contrast to forced air, the carbon polymer is reusable and has lower running-costs so is likely to be cheaper in the long term. This is particularly relevant in the day surgery setting where high numbers of patients are operated on. Additionally, and unlike the forced air warmers, the blanket can run on a battery so it can be applied from the moment the patient goes to sleep to the moment they wake up so it could actually prove more effective at preventing hypothermia in the clinical setting. This study aims to determine whether the carbon polymer blankets can reduce the incidence of hypothermia in the day surgery (ie. short operating time) setting.
详细描述
Recently published NICE guidelines recommend using fluid warmers for all infusions of 500mls or more and forced-air warming blankets for all main theatre operations. These guidelines have been extrapolated from work done on longer operations.
Patients whose temperature drops below 36 degrees Centigrade during or after surgery suffer more complications and blood loss than those whose temperature remains above 36 degrees Centigrade. They also often require more blood transfusions and stay in hospital for longer. Some of these complications are more common even when the temperature drops below 36.5.
Disposable forced-air warming blankets prevent hypothermia, but cannot be re-used and therefore incur a significant expense in terms of consumables.
Re-usable carbon polymer blankets, such as the HotDog, have been shown to not only be effective in preventing hypothermia, but have also been shown to maintain core temperature as effectively as forced air blankets.
Carbon polymer blankets are re-usable, with the added associated benefit of lower running costs. Therefore, in the face of limited NHS resources a reusable money saving alternative, such as the carbon polymer HotDog, would be a preferred option to the disposable forced air blanket.
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
- 是
入选标准
- •All patients, who are scheduled for non-emergency daycase surgery which will take place with them in the supine position
排除标准
- •Those patients who refuse
- •Who are unable to fully understand the trial and give valid
- •Informed consent; OR
- •Who will not be positioned supine on the operating table
结局指标
主要结局
Core temperature
时间窗: Every 15 minutes
Temperatures will be taken: Preoperatively on the day case unit ward, At the beginning of the operation Every 15 minutes thereafter intraoperatively. At the end of the operation in recovery Every 30 minutes until discharged home.
次要结局
- Total blood loss(At the end of the operative procedure)
- Blood transfusion(From the start of the operation until discharge. If patient is re-admitted within 24 hours requiring blood transfusion - also be counted)
- Wound infection(Upon patient discharge/ At GP follow-up at one month)
- Shivering (need for treatment or not)(Recorded during recovery stay)
- Time in recovery(Recorded during recovery stay)
- Time taken for patient to be considered fit for discharge i.e. length of hospital stay.(Upon discharge from hospital)