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Office Blood Pressure Measurement With an Automated Device

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: NCT03460249
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Roy Morcos, Mercy Health Ohio

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Other: BP measurement Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Office Blood Pressure Measurement With an Automated Device
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : August 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: BP table or chair, systolic or diastolic
record the BP obtained in each patient position
 Other: BP measurement
the BP will be measured in the chair position followed by the table position and also in the reverse sequence
Active Comparator: as above
as above
 Other: BP measurement
the BP will be measured in the chair position followed by the table position and also in the reverse sequence


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning [ Time Frame: 4 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
Contacts and Locations
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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): NCT03460249


Locations
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United States, Ohio
Mercy Health Youngstown
Youngstown, Ohio, United States, 44501
Sponsors and Collaborators
Mercy Health Ohio
More Information
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Responsible Party: Roy Morcos, M.D., Associate Professor of Family and Community Medicine, Mercy Health Ohio
ClinicalTrials.gov Identifier: NCT03460249    
Other Study ID Numbers: 17-015
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
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
Product Manufactured in and Exported from the U.S.: No