Study of Patient Compliance and Comfort Using Sequential Compression Devices and Foot Pumps for DVT Prevention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Patient Compliance
研究概览
简要总结
The researchers at Johns Hopkins University believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (DVT) in pregnancy.
详细描述
The investigators will be comparing sequential compression devices (SCDs) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. Patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive SCDs or the foot pump as part of their thromboembolic prophylaxis regimen. The investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). Random spot checks to verify compliance will be performed.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thrombophilia
- •Prescribed DVT prophylaxis
排除标准
- •Active DVT
研究组 & 干预措施
1
Patients will have the Kendall, A-V foot impulse pump, model 6060 applied to their lower extremities to prevent DVT
干预措施: Kendall A-V foot impulse pump, model 6060 (Device)
2
Patients will have the Kendall,sequential compression device, model 9525 applied to the lower extremities to prevent DVT
干预措施: Kendall sequential compression device, model 9525 (Device)
结局指标
主要结局
Patient Compliance
时间窗: for 1-7 days during hospitalization
Nurse conducting random checks throughout hospital stay and events of noncompliance will be recorded
Comfort Level
时间窗: once during first 7 days of hospitalization
Scale of 1-10 (1 being very uncomfortable and 10 being very uncomfortable) describing level of comfort during the time of device use (composite score of heat, softness, discomfort).
次要结局
- DVT Prevention(up to 3 months)