一项使用健康志愿者将动力移植骨髓穿刺程序与手动标准骨髓穿刺程序进行比较的研究
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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San Antonio、Texas、美国、78217
- Medical Therapy and Research LLC.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 21 岁及以上的成年人
- 能够俯卧在桌子上长达 1 小时
- 自我报告健康,经研究者在病史回顾和体格检查中确认
- 筛查访视时尿妊娠试验阴性的女性受试者
排除标准:
- 筛选访视后 7 天内报告发烧
- 筛查访视后 7 天内报告活动性感染
- 研究程序当天发烧
- 研究程序当天活动性感染的体征/症状
- 入狱
- 自我认定为怀孕或哺乳期
- 认知障碍
- 患有一种或多种无法进行骨髓穿刺的疾病的患者
- 目标骨中组织过多和/或缺乏足够的解剖学标志
- 对局部麻醉剂过敏
- 俯卧时无法平躺
- 凝血酶原时间和国际标准化比率 (PT/INR) 结果超出筛选实验室工作的正常范围,并且被研究者认为具有临床意义
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Group 1: First Procedure: Jamshidi Manual Standard Device
The Jamshidi manual standard device procedure will be performed first.
The OnControl Powered Ported device procedure will be performed second.
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Jamshidi 手动标准装置
OnControl 供电的移植设备
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其他:Group 2: First Procedure OnControl Powered Ported Device
The OnControl power ported device procedure will be performed first.
The Jamshidi manual standard device procedure will be performed second.
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Jamshidi 手动标准装置
OnControl 供电的移植设备
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Aspirate Specimen Yield Total Score -Jamshidi Manual Standard Device
大体时间:analyzed and results received within 30 days of Day 1 procedures
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The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
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analyzed and results received within 30 days of Day 1 procedures
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Quality of Aspirate Specimen Yield Total Score -OnControl Power Ported Device
大体时间:analyzed and results received within 30 days of Day 1 procedures
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The Quality of Aspirate Specimen Yield Total Score is a sum score using the 3 quality rating scales below. The Score range: 0 to 8; Higher scores mean greater quality. Direct Smears- Cellularity: 0= obviously dilute, no good particles or adequate megakaryocytes (MK)
Particle Crush Smears: Evaluate presence of particles and quality of cellularity: 0= no particles
Clot Sections: Evaluate quantity and quality of particles 0= insufficient or no particles for interpretation
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analyzed and results received within 30 days of Day 1 procedures
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Level of Pain With Needle Insertion- Jamshidi Manual Standard Device
大体时间:Day 1 at time of procedure
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Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst.
Higher numbers indicate greater pain.
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Day 1 at time of procedure
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Level of Pain With Needle Insertion- OnControl Power Ported Device
大体时间:Day 1 at time of procedure
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Subject reported level of pain with needle insertion (insertion of the bone marrow aspiration device, OnControl or Jamshidi, into the bone marrow space of the iliac crest) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst.
Higher numbers indicate greater pain.
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Day 1 at time of procedure
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Level of Pain With Aspiration - Jamshidi Manual Standard Device
大体时间:1 Day at time of the procedure
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Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst.
Higher numbers indicate greater pain.
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1 Day at time of the procedure
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Level of Pain With Aspiration - OnControl Power Ported Device
大体时间:1 Day at time of the procedure
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Subject reported level of pain with aspiration (withdrawing the bone marrow aspirate specimen with syringe) was reported by the patients for each procedure performed using the Wong-Baker FACES Pain Rating Scale Where 0 = no hurt and 10 = hurts worst.
Higher numbers indicate greater pain.
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1 Day at time of the procedure
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Time to Insertion - Jamshidi Manual Standard Device
大体时间:1 Day, during procedure
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Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space
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1 Day, during procedure
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Time to Insertion - OnControl Power Ported Device
大体时间:1 Day, during procedure
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Time recorded in seconds from contact of the device and the periosteum of the iliac crest to insertion of the needle through the cortex into the medullary space
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1 Day, during procedure
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Time for Aspirate Collection - Jamshidi Manual Standard Device
大体时间:1 Day, during procedure
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Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition
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1 Day, during procedure
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Time for Aspirate Collection - OnControl Power Ported Device
大体时间:1 Day, during procedure
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Time recorded in seconds from contact of the device and the periosteum of the iliac crest to removal of the needle from the medullary cavity following aspirate sample acquisition
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1 Day, during procedure
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2014-12 (AP HM)
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