Data from: Cohort feasibility study of an intermittent pneumatic compression device within a below-knee cast for the prevention of venous thromboembolism

Objectives: To determine the likely enrolment rate of eligible participants into a randomised controlled trial (RCT) in which a within-cast intermittent pneumatic compression device using Jet Impulse Technology (IPC/JIT) is 1 of 3 possible interventions in a RCT for the prevention of venous thromboembolism (VTE) in the clinical setting of isolated lower limb cast immobilisation. Design: A prospective, open-label feasibility study of the IPC/JIT device placed within a lower limb cast. Setting: Wellington Regional Hospital Fracture Clinic. Participants: Individuals aged 18–70 who presented with a lower limb injury requiring a minimum of 4 weeks below-knee cast immobilisation. Intervention: Placement of an IPC/JIT device within lower limb cast. Outcome measures: The main outcome measure was the proportion of eligible participants who participated in the feasibility study. Secondary outcome measures included adherence to device usage throughout the study, ease of application of the device and adverse events potentially associated with its use. Results: The proportion of potentially eligible participants for the IPC/JIT device was only 7/142 (5%), 95% CI 2 to 9.9. Devices were used for a mean (range) of 4.1 (1.9 to 10.2) hours per day and none of 7 participants had adequate adherence to the device. 3 of the 7 participants suffered an adverse event, including 1 deep vein thrombosis, 2 dorsal foot ulcer and 1 skin maceration. Conclusions: A within-cast IPC/JIT device is unlikely to be a feasible randomisation arm for a RCT assessing possible interventions for the reduction of VTE risk in the clinical setting of lower limb injury requiring below knee cast immobilisation for a minimum of 4 weeks.

研究目的：明确在单纯下肢石膏固定的临床场景中，针对静脉血栓栓塞症（Venous Thromboembolism, VTE）预防的随机对照试验（randomised controlled trial, RCT）的符合入组标准受试者的潜在入组率。该试验将采用搭载喷射脉冲技术（Jet Impulse Technology, JIT）的石膏内间歇性充气加压（Intermittent Pneumatic Compression, IPC）装置作为3种可选干预措施之一。
研究设计：一项针对下肢石膏内放置IPC/JIT装置的前瞻性、开放标签可行性研究。
研究地点：惠灵顿地区医院骨折门诊。
研究对象：年龄18~70岁，因下肢损伤需接受至少4周膝下石膏固定的个体。
干预措施：在下肢石膏内放置IPC/JIT装置。
结局指标：主要结局指标为符合入组条件的受试者参与本可行性研究的比例；次要结局指标包括研究全程的装置使用依从性、装置佩戴难度，以及可能与装置使用相关的不良事件。
研究结果：符合IPC/JIT装置入组条件的潜在受试者仅为7/142（5%），95%置信区间（CI）为2%至9.9%。受试者日均装置使用时长为平均4.1小时（范围1.9至10.2小时），7名受试者均未达到足够的装置使用依从性。7名受试者中有3名出现不良事件，包括1例深静脉血栓、2例足背溃疡及1例皮肤浸渍。
研究结论：针对需接受至少4周膝下石膏固定的下肢损伤患者，旨在降低静脉血栓栓塞症风险的随机对照试验中，石膏内置入IPC/JIT装置作为随机分组干预措施的可行性较低。