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

NCT04610775 | Completed

• 1 other identifier: IRB00252142
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Difference in blood pressure based on hypertension status

  Up to 90 minutes

• Difference in blood pressure based on arm circumference

  Up to 90 minutes

• Difference in blood pressure based on BMI

  Up to 90 minutes

Study Arms (24)

Small Cuff (0, +1, +2, 0)

OTHER

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

Small Cuff (0, +2, +1, 0)

OTHER

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

Small Cuff ( +1, 0, +2, 0)

OTHER

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

Small Cuff ( +1, +2, 0, 0)

OTHER

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

Small Cuff ( +2, 0, +1, 0)

OTHER

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

Small Cuff ( +2, +1, 0, 0)

OTHER

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

Regular Cuff (0, -1, +1, 0)

OTHER

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

Regular Cuff (0, +1, -1, 0)

OTHER

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

Regular Cuff (-1, 0, +1, 0)

OTHER

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

Regular Cuff (-1, +1, 0, 0)

OTHER

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

Regular Cuff (+1, -1, 0, 0)

OTHER

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

Regular Cuff (+1, 0, -1, 0)

OTHER

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

Large Cuff (-1, 0, +1, 0)

OTHER

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

Large Cuff (-1, +1, 0, 0)

OTHER

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

Large Cuff (0, +1, -1, 0)

OTHER

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

Large Cuff (0, -1, +1, 0)

OTHER

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

Large Cuff (+1, 0, -1, 0)

OTHER

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

Large Cuff (+1, -1, 0, 0)

OTHER

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

Extra Large Cuff (0, -2, -1, 0)

OTHER

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

Extra Large Cuff (0, -1, -2, 0)

OTHER

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

Extra Large Cuff (-1, 0, -2, 0)

OTHER

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

Extra Large Cuff (-1, -2, 0, 0)

OTHER

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

Extra Large Cuff (-2, -1, 0, 0)

OTHER

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

Extra Large Cuff (-2, 0, -1 0)

OTHER

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

Interventions

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.

Extra Large Cuff (-1, -2, 0, 0); Extra Large Cuff (-1, 0, -2, 0); Extra Large Cuff (-2, -1, 0, 0); Extra Large Cuff (-2, 0, -1 0); Extra Large Cuff (0, -1, -2, 0); Extra Large Cuff (0, -2, -1, 0); Large Cuff (+1, -1, 0, 0); Large Cuff (+1, 0, -1, 0); Large Cuff (-1, +1, 0, 0); Large Cuff (-1, 0, +1, 0); Large Cuff (0, +1, -1, 0); Large Cuff (0, -1, +1, 0); Regular Cuff (+1, -1, 0, 0); Regular Cuff (+1, 0, -1, 0); Regular Cuff (-1, +1, 0, 0); Regular Cuff (-1, 0, +1, 0); Regular Cuff (0, +1, -1, 0); Regular Cuff (0, -1, +1, 0); Small Cuff ( +1, +2, 0, 0); Small Cuff ( +1, 0, +2, 0); Small Cuff ( +2, +1, 0, 0); Small Cuff ( +2, 0, +1, 0); Small Cuff (0, +1, +2, 0); Small Cuff (0, +2, +1, 0)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vital Strategies: collaborator

Study Sites (1)

Johns Hopkins ProHealth Research Center

Baltimore, Maryland, 21207, United States

Location

Related Publications (1)

• Ishigami J, Charleston J, Miller ER 3rd, Matsushita K, Appel LJ, Brady TM. Effects of Cuff Size on the Accuracy of Blood Pressure Readings: The Cuff(SZ) Randomized Crossover Trial. JAMA Intern Med. 2023 Oct 1;183(10):1061-1068. doi: 10.1001/jamainternmed.2023.3264.

  PMID: 37548984 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Tammy Brady, MD,Phd

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 2, 2020
• Study Start: March 16, 2021
• Primary Completion: October 25, 2021
• Study Completion: October 25, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)