Nuffield Department of Medicine, University of Oxford, Oxford, UK.
East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.
J Hosp Infect. 2019 Dec;103(4):412-419. doi: 10.1016/j.jhin.2019.08.019. Epub 2019 Sep 4.
Active warming during surgery prevents perioperative hypothermia but the effectiveness and postoperative infection rates may differ between warming technologies.
To establish the recruitment and data management strategies needed for a full trial comparing postoperative infection rates associated with forced air warming (FAW) versus resistive fabric warming (RFW) in patients aged >65 years undergoing hemiarthroplasty following fractured neck of femur.
Participants were randomized 1:1 in permuted blocks to FAW or RFW. Hypothermia was defined as a temperature of <36°C at the end of surgery. Primary outcomes were the number of participants recruited and the number with definitive deep surgical site infections.
A total of 515 participants were randomized at six sites over a period of 18 months. Follow-up was completed for 70.1%. Thirty-seven participants were hypothermic (7.5% in the FAW group; 9.7% in the RFW group). The mean temperatures before anaesthesia and at the end of surgery were similar. For the primary clinical outcome, there were four deep surgical site infections in the FAW group and three in the RFW group. All participants who developed a postoperative infection had antibiotic prophylaxis, a cemented prosthesis, and were operated under laminar airflow; none was hypothermic. There were no serious adverse events related to warming.
Surgical site infections were identified in both groups. Progression from the pilot to the full trial is possible but will need to take account of the high attrition rate.
手术期间主动升温可预防围手术期低体温，但不同的升温技术在有效性和术后感染率方面可能存在差异。
确定一项比较全髋关节置换术后感染率的试验所需的招募和数据管理策略，该试验比较了在因股骨颈骨折行半髋关节置换术的>65 岁患者中使用强制空气加热（FAW）与电阻织物加热（RFW）的效果。
参与者以 1:1 的比例按区组随机分为 FAW 或 RFW 组。低体温定义为手术结束时体温<36°C。主要结局为招募的参与者人数和明确的深部手术部位感染人数。
在 18 个月的时间里，共有 515 名参与者在 6 个地点被随机分组。完成了 70.1%的随访。37 名参与者出现低体温（FAW 组 7.5%；RFW 组 9.7%）。麻醉前和手术结束时的平均温度相似。对于主要临床结局，FAW 组有 4 例深部手术部位感染，RFW 组有 3 例。所有发生术后感染的患者均接受了抗生素预防治疗、骨水泥假体，并在层流空气下进行了手术；均无低体温。没有与加热相关的严重不良事件。
两组均发现了手术部位感染。从试点到全面试验的推进是可行的，但需要考虑到高失访率。
