Best Rest: Rest Time Before Blood Pressure Measurement Trial

Hypertension Clinical Trial

Official title:

Rest Time Before Blood Pressure Measurement Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031768
• Other study ID #: IRB00214827
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: September 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Hypertension

Intervention

Other:
• Timing of rest prior to blood pressure measurement
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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine Division of Pediatric Nephrology	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Vital Strategies

Country where clinical trial is conducted

United States, 

References & Publications (1)

Brady TM, Charleston J, Ishigami J, Miller ER 3rd, Matsushita K, Appel LJ. Effects of Different Rest Period Durations Prior to Blood Pressure Measurement: The Best Rest Trial. Hypertension. 2021 Nov;78(5):1511-1519. doi: 10.1161/HYPERTENSIONAHA.121.17496. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total time required to obtain a BP measurement (seconds)	For each rest time assignment, mean time from: Seating -> cuff placement; Cuff placement -> first measurement; Start of cuff inflation to measurement completion/BP output on device; Overall: Time from seating -> completion of all 3 BP measurements, 30 seconds apart.	90 minutes
Primary	Difference in Systolic Blood Pressure (mmHg)	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
Primary	Difference in Diastolic Blood Pressure (mmHg)	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
Secondary	Blood Pressure Variability (mmHg)	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
Secondary	Standard Deviation of Blood Pressures (mmHg)	Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period	90 minutes
Secondary	Coefficient of Variation of Blood Pressures	Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period	90 minutes