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Completed

NCT Number: NCT04031768

Best Rest: Rest Time Before Blood Pressure Measurement Trial

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.

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Key information

Conditions

Hypertension Blood Pressure Cardiovascular Diseases Cardiovascular Risk Factor Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine Division of Pediatric Nephrology

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Timing of rest prior to blood pressure measurement

Other

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.

Primary outcomes

  1. Difference in Systolic Blood Pressure (mmHg)

    Time frame: 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)

  2. Difference in Diastolic Blood Pressure (mmHg)

    Time frame: 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 outcomes

  1. Blood Pressure Variability (mmHg)

    Time frame: 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

  2. Standard Deviation of Blood Pressures (mmHg)

    Time frame: 90 minutes

    Difference in standard deviation of the mean of 3 systolic and diastolic BPs obtained at each rest period

  3. Coefficient of Variation of Blood Pressures

    Time frame: 90 minutes

    Difference in coefficient of variation (SD/mean) of 3 systolic and diastolic BPs obtained at each rest period

Other outcomes

  1. Total time required to obtain a BP measurement (seconds)

    Time frame: 90 minutes

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Vital Strategies

Registry information

Official study title

Rest Time Before Blood Pressure Measurement Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2019
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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