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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06119412
Other study ID # GaziU-SBF-EE-02
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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