Office Blood Pressure Measurement With an Automated Device

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Other: BP measurement

• Registration Number: NCT03460249
• Lead Sponsor: Mercy Health Ohio

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.

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-09
• Study Start: 2018-04-02
• Primary Completion: 2018-07-02
• Study Completion: 2018-08-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-02
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
as above	BP measurement	as above
BP table or chair, systolic or diastolic	BP measurement	record the BP obtained in each patient position

Primary Outcome Measures

Name	Time	Method
Percentage of participants whose blood pressures differ with chair to table versus table to chair positioning	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.

Trial Locations

Locations (1)

Mercy Health Youngstown; 🇺🇸 Youngstown, Ohio, United States