Best Rest: Rest Time Before Blood Pressure Measurement Trial

Not Applicable

Completed

• Conditions: Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor
• Interventions: Other: Timing of rest prior to blood pressure measurement

• Registration Number: NCT04031768
• Lead Sponsor: Johns Hopkins University

Brief Summary

The objectives of this study are to:

1. Determine the impact of wait time before initiating BP measurement on BP variability

2. 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Study Start: 2019-11-11
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0-2-5-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 0 minutes 2 minutes 5 minutes 5 minutes
5-0-2-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 5 minutes 0 minutes 2 minutes 5 minutes
0-5-2-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 0 minutes 5 minutes 2 minutes 5 minutes
2-0-5-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 2 minutes 0 minutes 5 minutes 5 minutes
5-2-0-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 5 minutes 2 minutes 0 minutes 5 minutes
2-5-0-5 minutes rest group	Timing of rest prior to blood pressure measurement	The order of rest periods for participants randomized to this arm will be: 2 minutes 5 minutes 0 minutes 5 minutes

Primary Outcome Measures

Name	Time	Method
Difference in Systolic Blood Pressure (mmHg)	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)
Difference in Diastolic Blood Pressure (mmHg)	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)

Secondary Outcome Measures

Name	Time	Method
Coefficient of Variation of Blood Pressures	90 minutes	Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period
Blood Pressure Variability (mmHg)	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
Standard Deviation of Blood Pressures (mmHg)	90 minutes	Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period

Trial Locations

Locations (1)

Johns Hopkins School of Medicine Division of Pediatric Nephrology; 🇺🇸 Baltimore, Maryland, United States