HypertensionNCT04610775
Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
A study testing Order of cuff sizes during blood pressure measurements in people with Hypertension and Blood Pressure, run by Johns Hopkins University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure, Cardiovascular Diseases
- What is being tested?
- Order of cuff sizes during blood pressure measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 25 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins ProHealth Research Center
Baltimore, Maryland, 21207
About this study
Official title: 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:
- Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive.
- Arm circumference (continuous)
- Obesity status
Read the 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.
- Being tested
- Order of cuff sizes during blood pressure measurements
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Order of cuff sizes during blood pressure measurementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Order of cuff sizes during blood pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to 90 minutes
Secondary outcomes (3)
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.
Measured: Up to 90 minutes
Difference in blood pressure based on arm circumference
To determine the blood pressure difference based on arm circumference (continuous).
Measured: 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).
Measured: Up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start16 Mar 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Vital Strategies
- Responsible party
- Sponsor
- Investigators
- Tammy Brady, MD,Phd, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610775
- Sponsor's protocol ID
- IRB00252142
- Status last verified
- Mar 2021
- First submitted
- 26 Oct 2020
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37548984
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cuff Size Blood Pressure Measurement Trial
- ClinicalTrials.gov ID
- NCT04610775
- Acronym / sponsor ID
- IRB00252142
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Vital Strategies
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs. non-hypertensive.
- Arm circumference (continuous)
- Obesity status
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| Small Cuff (0, +1, +2, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Small |
| Small Cuff (0, +2, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Small |
| Small Cuff ( +1, 0, +2, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Small |
| Small Cuff ( +1, +2, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Small |
| Small Cuff ( +2, 0, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Small |
| Small Cuff ( +2, +1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Small |
| Regular Cuff (0, -1, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Small, Large, Regular |
| Regular Cuff (0, +1, -1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Small, Regular |
| Regular Cuff (-1, 0, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Small, Regular, Large, Regular |
| Regular Cuff (-1, +1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Small, Large, Regular, Regular |
| Regular Cuff (+1, -1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Small, Regular, Regular |
| Regular Cuff (+1, 0, -1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Small, Regular |
| Large Cuff (-1, 0, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Large |
| Large Cuff (-1, +1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Large |
| Large Cuff (0, +1, -1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Large |
| Large Cuff (0, -1, +1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Large |
| Large Cuff (+1, 0, -1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Large |
| Large Cuff (+1, -1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Large |
| Extra Large Cuff (0, -2, -1, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Regular, Large, Extra Large |
| Extra Large Cuff (0, -1, -2, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Extra Large, Large, Regular, Extra Large |
| Extra Large Cuff (-1, 0, -2, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Extra Large, Regular, Extra Large |
| Extra Large Cuff (-1, -2, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Large, Regular, Extra Large, Extra Large |
| Extra Large Cuff (-2, -1, 0, 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Large, Extra Large, Extra Large |
| Extra Large Cuff (-2, 0, -1 0) | Other | Other: Order of cuff sizes during blood pressure measurementsThe order of blood pressure cuffs used for participants randomized to this arm will be: Regular, Extra Large, Large, Extra Large |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Order of cuff sizes during blood pressure measurementsEach 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), 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) |
Primary outcome
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).
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).
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).
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).
3 secondary outcomes
Difference in blood pressure based on hypertension status
Time frame: Up to 90 minutes
Difference in blood pressure based on arm circumference
Time frame: Up to 90 minutes
Difference in blood pressure based on BMI
Time frame: Up to 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 37548984Ishigami 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tammy Brady, MD,Phd principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Order of cuff sizes during blood pressure measurements in people with Hypertension and Blood Pressure, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in systolic BP in appropriately-sized cuff vs. too small cuff (time frame: Up to 90 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04610775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.