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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610775
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
Vital Strategies
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure Cardiovascular Diseases Cardiovascular Risk Factor Other: Order of cuff sizes during blood pressure measurements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Cuff Size Blood Pressure Measurement Trial
Actual Study Start Date : March 16, 2021
Actual Primary Completion Date : October 25, 2021
Actual Study Completion Date : October 25, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610775


Locations
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United States, Maryland
Johns Hopkins ProHealth Research Center
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Johns Hopkins University
Vital Strategies
Investigators
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Principal Investigator: Tammy Brady, MD,Phd Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04610775    
Other Study ID Numbers: IRB00252142
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases