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临床试验/NCT03460249
NCT03460249已完成不适用

Office Blood Pressure Measurement With an Automated Device

Mercy Health Ohio2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning

研究概览

简要总结

The investigators plan to determine if the sequence of blood pressure measurements from the sitting position to the table and vice versa has an impact on the measurements.

详细描述

The investigators plan to measure blood pressure (BP) in 30 consecutive individuals presenting to the St. Elizabeth Boardman Family Health Center. The sample will include patients presenting for their scheduled appointment. Following informed consent (see attached informed consent form), the participants will be randomly assigned to one of two groups. In group A, the sequence of BP measurements will be table position (TP) followed by recommended chair position (RCP) and then, after a 30-minutes rest, the BP will be measured again in the reverse sequence, RCP then TP. In group B, the sequence will begin with BP measurements in the RCP then TP, followed by 30-minutes rest and then measurements will be repeated in the reverse order. The assignment of participants to groups A and B will be random. The BP will be measured twice in each of the positions described above, according the the accepted standard technique, using a digital blood pressure monitor, the OMRON HEM-907 XL.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting to the Family Medicine Center age between 18 and 80

排除标准

  • Decline to participate for any reason
  • Experiencing acute pain or febrile illness
  • Inability to get on the examination table
  • Atrial fibrillation, arrhythmia or tachycardia

研究组 & 干预措施

BP table or chair, systolic or diastolic

Active Comparator

record the BP obtained in each patient position

干预措施: BP measurement (Other)

as above

Active Comparator

as above

干预措施: BP measurement (Other)

结局指标

主要结局

Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning

时间窗: 4 months

Chair to table versus table to chair positional differences in mean systolic and diastolic blood pressures in mm Hg are determined for each participant using an oscillometric device. The percentage of individuals with significant differences in positional blood pressure readings leading to inconsistent blood pressure health status classification will be calculated and reported.

次要结局

未报告次要终点

研究者

发起方
Mercy Health Ohio
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roy Morcos

M.D., Associate Professor of Family and Community Medicine

Mercy Health Ohio

研究点 (2)

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