Best Rest: Rest Time Before Blood Pressure Measurement Trial
2022年9月1日 更新者：Johns Hopkins University
Rest Time Before Blood Pressure Measurement Trial
The objectives of this study are to:
- Determine the impact of wait time before initiating BP measurement on BP variability
- Determine the difference in BP variability between measurements by amount of initial rest.
The investigators also aim to:
1. To determine the total time required to obtain a BP measurement.
研究概览
详细说明
Hypertension guidelines recommend a minimum of five minute rest time prior to blood pressure (BP) measurements obtained for screening, diagnosis and management of hypertension.
This recommended wait time is often not adhered to and is cited as a barrier to regular screening due to length of time, clinic workflow and provider burden.
It is unclear if BPs obtained at different rest intervals would provide clinically similar measurements.
This study therefore aims to determine if BPs obtained immediately or after 2 minutes are rest are non-inferior to the BPs obtained after the guideline recommended 5 minutes of rest.
It also aims to determine the time required to measure BP from start to finish, to allow for easier identification of other potential barriers to regular BP screening practices in busy clinical settings.
研究类型
介入性
注册 (实际的)
116
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- Johns Hopkins School of Medicine Division of Pediatric Nephrology
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 18-80 years
Exclusion Criteria:
- Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
- Being mentally impaired, pregnant.
- Arm circumference exceeding 50 cm.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：0-2-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
其他：0-5-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
其他：2-0-5-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
其他：5-0-2-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
其他：2-5-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
|
其他：5-2-0-5 minutes rest group
The order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes |
Each participant will have 4 sets of 3 blood pressure measurements taken.
The participants will be randomized to the order in which they rest prior to each set of measurements.
|
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 |
|---|---|---|
|
Difference in Systolic Blood Pressure (mmHg)
大体时间：90 minutes
|
Comparison of the average of 3 systolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 systolic blood pressure (SBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
|
Difference in Diastolic Blood Pressure (mmHg)
大体时间：90 minutes
|
Comparison of the average of 3 diastolic BP measurements (mmHg) measured after 5 minutes rest with the average of 3 diastolic blood pressure (DBP) measured after the other periods of rest (0 minutes, 2 minutes, second 5 minutes of rest)
|
90 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure Variability (mmHg)
大体时间：90 minutes
|
Difference between individual systolic and diastolic BP measurements (BP reading 1 - BP reading 2; BP reading 2 - BP reading 3) obtained per each rest period
|
90 minutes
|
|
Standard Deviation of Blood Pressures (mmHg)
大体时间：90 minutes
|
Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
|
Coefficient of Variation of Blood Pressures
大体时间：90 minutes
|
Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period
|
90 minutes
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total time required to obtain a BP measurement (seconds)
大体时间：90 minutes
|
For each rest time assignment, mean time from:
|
90 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Tammy Brady, MD, PhD、Johns Hopkins University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月11日
初级完成 (实际的)
2020年3月16日
研究完成 (实际的)
2020年3月16日
研究注册日期
首次提交
2019年7月22日
首先提交符合 QC 标准的
2019年7月22日
首次发布 (实际的)
2019年7月24日
研究记录更新
最后更新发布 (实际的)
2022年9月6日
上次提交的符合 QC 标准的更新
2022年9月1日
最后验证
2022年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00214827
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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不
研究美国 FDA 监管的设备产品
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