An Alternative Technique for Measuring Blood Pressure

Healthy Clinical Trial

Official title:

An Alternative Technique for Measuring Blood Pressure

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06119412
• Other study ID #: GaziU-SBF-EE-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This cross design study will be conducted to evaluate the combination of palpation and auscultation techniques as an alternative technique for the measurement of blood pressure. The main questions it aims to answer are:

• Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique?

• Is there a statistical difference between the results of systolic blood pressure measured with the old and new technique? Participants' blood pressure will be measured twice.

Description:

As a result of clinical observations, a common practice is to inflate the cuff to a high and random mmHg value and start auscultation directly. Alternatively, many healthcare workers determine the moment when pulse beats disappear by palpation and increase this value by 30 mmHg without lowering the cuff and without taking a break for 1-2 minutes and start auscultation. In the literature, there is a similar technique called "one-step method". According to this technique, the sphygmomanometer is wrapped around the individual's arm and the stethoscope is placed in the ear. The brachial artery is then palpated and identified. The cuff is inflated up to 30 mmHg above the systolic blood pressure of the individual. The cuff is then depressurized to 2-3 mmHg/second. It is observed that many healthcare professionals and students use this technique today because it is more practical in terms of measurement time. However, it is thought that the step of "inflating the cuff up to 30 mmHg above the systolic blood pressure value of the individual" in the process steps of the technique is not reliable enough. It is thought that it may lead to erroneous results in capturing sudden blood pressure changes in the individual. In this context, it is thought that it would be more reliable to determine the value at the moment when the pulse is not felt with the palpation technique, add 30 mmHg to this value without interruption and without lowering the cuff and continue auscultation. At the same time, combining palpation and auscultation and continuing them consecutively will shorten the measurement time and provide a practical application.

It is aimed to measure blood pressure in approximately 202 healthy adults. The purpose and method of the study will be explained in detail to all participants included in the sample group. Participants will be allowed to rest for 15-30 minutes before blood pressure measurement. Blood pressure will be measured with two different techniques according to the order in which the participants are included in the study. The first participant's blood pressure will first be measured with the standard technique in the literature (with a break between palpation and auscultation). After a 60-second pause, blood pressure will be measured with the alternative recommended technique (palpation and auscultation combined). In the second participant, blood pressure will be measured first with the alternative recommended technique (combining palpation and auscultation). After a 60-second break and with the arm in the same position, blood pressure will be measured with the standard technique in the literature (with a break between palpation and auscultation). The cross-over method will be applied as possible differences between measurement times should be taken into account.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 202
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Over 18 years of age,

• no chronic disease,

• not taking any medication and/or treatment that affects the cardiovascular or circulatory system,

• volunteering to participate in the research.

Exclusion Criteria:

• has a chronic disease,

• taking medication that affects the cardiovascular or circulatory system,

• wants to leave the study at any stage.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.
Each participant will have their blood pressure measured with two different techniques.

Locations

Country	Name	City	State
Turkey	Eyikara	Ankara
Turkey	Gazi University Department of Health Sciences	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood pressure measurement list	This form will record the participant's systolic and diastolic blood pressure measured with the standard technique and the alternative new technique.	approximately 12 weeks from the start of measurements until reporting.
Secondary	blood pressure measurement time	The number of seconds the blood pressure measurements last will be recorded.	approximately 12 weeks from the start of measurements until reporting.