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Completed

NCT Number: NCT04610775

Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial

To determine the impact of overcuffing (using a too-large cuff) and undercuffing (using a too-small cuff) on initial BP and average BP measurements when using an automated BP device, overall and stratified by appropriate cuff size

To determine if the impact over- or under-cuffing differs based on the following patient characteristics:

1. Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive. 2. Arm circumference (continuous) 3. Obesity status

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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 ProHealth Research Center

Baltimore, Maryland, 21207, United States

About this study

The investigators propose a cross-sectional study of adult participants recruited from the community. Enrolled participants will have 2-3 sets of three automated BPs measured, each set with a different cuff size. To accomplish this, the investigators will utilize a 2-3 period cross-over design:

  • Two or three different periods with 3 automated BP measurements, using a BP cuff that is:
  • Appropriately sized based on mid-upper arm circumference ( standard)
  • Too small (one size lower than appropriate)
  • Too large (one size higher than appropriate)

Individuals in whom the smallest available cuff (small adult) and largest available cuff (extra-large cuff) is appropriate for their arm circumference will only be able to undergo two periods of BP measurements.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-80

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

Order of cuff sizes during blood pressure measurements

Other

Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the cuff sizes are used.

Primary outcomes

  1. Difference in systolic BP in appropriately-sized cuff vs. too small cuff

    Time frame: Up to 90 minutes

    Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg).

  2. Difference in systolic BP in appropriately-sized cuff vs. too large cuff

    Time frame: Up to 90 minutes

    Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg).

  3. Difference in diastolic BP in appropriately-sized cuff vs. too small cuff

    Time frame: Up to 90 minutes

    Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).

  4. Difference in diastolic BP in appropriately-sized cuff vs. too large cuff

    Time frame: Up to 90 minutes

    Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).

Secondary outcomes

  1. Difference in blood pressure based on hypertension status

    Time frame: Up to 90 minutes

    To determine the blood pressure difference based on hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive participants.

  2. Difference in blood pressure based on arm circumference

    Time frame: Up to 90 minutes

    To determine the blood pressure difference based on arm circumference (continuous).

  3. Difference in blood pressure based on BMI

    Time frame: Up to 90 minutes

    To determine the blood pressure difference based on normal BMI (<25 kg/m2) vs. overweight BMI (25 kg/m2-29.99 kg/m2) vs. Class I Obesity (30 kg/m2-34.99 kg/m2) vs. ≥Class II Obesity (>35 kg/m2).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Vital Strategies

Registry information

Official study title

The Cuff Size Blood Pressure Measurement Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Dec 13, 2021

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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