Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
NCT ID: NCT04610775
Last Updated: 2021-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
194 participants
INTERVENTIONAL
2021-03-16
2021-10-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
• 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Being mentally impaired, pregnant.
* Arm circumference exceeding 50 cm.
18 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vital Strategies
OTHER
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tammy Brady, MD,Phd
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Johns Hopkins ProHealth Research Center
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00252142
Identifier Type: -
Identifier Source: org_study_id