Office Blood Pressure Measurement With an Automated Device

NCT ID: NCT03460249

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2018-08-01

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.

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

BP table or chair, systolic or diastolic

record the BP obtained in each patient position

Group Type: ACTIVE_COMPARATOR

BP measurement

Intervention Type: OTHER

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

as above

as above

Group Type: ACTIVE_COMPARATOR

BP measurement

Intervention Type: OTHER

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

Interventions

BP measurement

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mercy Health Ohio

OTHER

Sponsor Role: lead

Responsible Party

Roy Morcos

M.D., Associate Professor of Family and Community Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mercy Health Youngstown

Youngstown, Ohio, United States

Countries

United States

Other Identifiers

17-015

Identifier Type: -

Identifier Source: org_study_id