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

Hypertension Clinical Trial

Official title:

The Cuff Size Blood Pressure Measurement Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610775
• Other study ID #: IRB00252142
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: October 25, 2021

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins ProHealth Research Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Vital Strategies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Difference in blood pressure based on arm circumference	To determine the blood pressure difference based on arm circumference (continuous).	Up to 90 minutes
Secondary	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