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

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Hypertension; Blood Pressure; Cardiovascular Risk Factor
• Intervention / Treatment: Other: Order of cuff sizes during blood pressure measurements

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21207
      • Johns Hopkins ProHealth Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

24

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Small Cuff (0, +1, +2, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Small Cuff (0, +2, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Small Cuff ( +1, 0, +2, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Small Cuff ( +1, +2, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Small Cuff ( +2, 0, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Small Cuff ( +2, +1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (0, -1, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (0, +1, -1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (-1, 0, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (-1, +1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (+1, -1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Regular Cuff (+1, 0, -1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (-1, 0, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (-1, +1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (0, +1, -1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (0, -1, +1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (+1, 0, -1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Large Cuff (+1, -1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (0, -2, -1, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (0, -1, -2, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (-1, 0, -2, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (-1, -2, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (-2, -1, 0, 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.
Other: Extra Large Cuff (-2, 0, -1 0); The order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large	Other: Order of cuff sizes during blood pressure measurements; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in systolic BP in appropriately-sized cuff vs. too small cuff	Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg).	Up to 90 minutes
Difference in systolic BP in appropriately-sized cuff vs. too large cuff	Difference between (1) 1st systolic BP and (2) average of 3 systolic BP from measurements (mmHg).	Up to 90 minutes
Difference in diastolic BP in appropriately-sized cuff vs. too small cuff	Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).	Up to 90 minutes
Difference in diastolic BP in appropriately-sized cuff vs. too large cuff	Difference between (1) 1st diastolic BP and (2) average of 3 diastolic BP from measurements (mmHg).	Up to 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in blood pressure based on hypertension status	To determine the blood pressure difference based on hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive participants.	Up to 90 minutes
Difference in blood pressure based on arm circumference	To determine the blood pressure difference based on arm circumference (continuous).	Up to 90 minutes
Difference in blood pressure based on BMI	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).	Up to 90 minutes

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Vital Strategies
• Investigators: Principal Investigator: Tammy Brady, MD,Phd, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: IRB00252142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No