CClinicalTrials.gg
CompletedNCT03460249Updated Sep 5, 2018

Office Blood Pressure Measurement With an Automated Device

An interventional study of BP measurement in Blood Pressure, sponsored by Mercy Health Ohio. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by Mercy Health Ohio · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The investigators plan to determine if the sequence of blood pressure measurements from the sitting position to the table and vice versa has an impact on the measurements.

Read the detailed description

The investigators plan to measure blood pressure (BP) in 30 consecutive individuals presenting to the St. Elizabeth Boardman Family Health Center. The sample will include patients presenting for their scheduled appointment. Following informed consent (see attached informed consent form), the participants will be randomly assigned to one of two groups. In group A, the sequence of BP measurements will be table position (TP) followed by recommended chair position (RCP) and then, after a 30-minutes rest, the BP will be measured again in the reverse sequence, RCP then TP. In group B, the sequence will begin with BP measurements in the RCP then TP, followed by 30-minutes rest and then measurements will be repeated in the reverse order. The assignment of participants to groups A and B will be random. The BP will be measured twice in each of the positions described above, according the the accepted standard technique, using a digital blood pressure monitor, the OMRON HEM-907 XL.

02

Conditions studied

  • Blood Pressure
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients presenting to the Family Medicine Center age between 18 and 80

Exclusion criteria

Exclusion Criteria:

  • Decline to participate for any reason
  • Experiencing acute pain or febrile illness
  • Pregnant
  • Inability to get on the examination table
  • Atrial fibrillation, arrhythmia or tachycardia
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    BP table or chair, systolic or diastolic

    record the BP obtained in each patient position

    Other: BP measurement

  • Active comparator
    as above

    as above

    Other: BP measurement

Interventions

  • OtherBP measurement

    the BP will be measured in the chair position followed by the table position and also in the reverse sequence

05

What researchers measure

Primary outcomes

  1. Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning

    Chair to table versus table to chair positional differences in mean systolic and diastolic blood pressures in mm Hg are determined for each participant using an oscillometric device. The percentage of individuals with significant differences in positional blood pressure readings leading to inconsistent blood pressure health status classification will be calculated and reported.

    Time frame: 4 months

06

Study locations

1 site
  • Mercy Health Youngstown
    Youngstown, Ohio 44501, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03460249
Lead sponsor
Mercy Health Ohio
Responsible party
Roy Morcos (M.D., Associate Professor of Family and Community Medicine, Mercy Health Ohio) — Principal investigator
First posted
Mar 9, 2018
Start date
Apr 2, 2018
Primary completion
Jul 2, 2018
Completion
Aug 1, 2018
Last update
Sep 5, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion