Office Blood Pressure Measurement With an Automated Device

Blood Pressure Clinical Trial

Official title:

Office Blood Pressure Measurement With an Automated Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460249
• Other study ID #: 17-015
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2018
• Source: Mercy Health Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2018
• Est. primary completion date: July 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• BP measurement
the BP will be measured in the chair position followed by the table position and also in the reverse sequence

Locations

Country	Name	City	State
United States	Mercy Health Youngstown	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Health Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months