HealthyNCT06119412
An Alternative Technique for Measuring Blood Pressure
A study testing blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used. in people with Healthy, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy
- What is being tested?
- blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- has a chronic disease,
- taking medication that affects the cardiovascular or circulatory system,
- wants to leave the study at any stage.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Department of Health Sciences
Ankara, 06490
About this study
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.Other
Each participant will have their blood pressure measured with two different techniques.
| Study group | Role | What they receive |
|---|---|---|
| group 1, starting with standard technique | Other | According to block randomization, the 1st researcher will first apply the standard technique (60 seconds pause between palpation and auscultation), 1 minute break will be given, and the 2nd researcher will apply the alternative new technique (no break between palpation and auscultation) on the same person. Receives: Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used. |
| group 2, starting with alternative new technique | Other | According to block randomization, Investigator 1 will first apply the alternative new technique (no pause between palpation and auscultation) to the people in the second group, and a 1-minute break will be given. The 2nd researcher will apply the standard technique (60 seconds break between palpation and auscultation) on the same person. Receives: Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 12 weeks from the start of measurements until reporting.
Secondary outcomes (1)
blood pressure measurement time
The number of seconds the blood pressure measurements last will be recorded.
Measured: approximately 12 weeks from the start of measurements until reporting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 Oct 2023
- Primary completion1 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evrim Eyikara, Gazi University
- Investigators
- Evrim Eyikara, Principal investigator, doctor research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119412
- Sponsor's protocol ID
- GaziU-SBF-EE-02
- Status last verified
- Nov 2024
- First submitted
- 20 Oct 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Technique for Measuring Blood Pressure
- ClinicalTrials.gov ID
- NCT06119412
- Acronym / sponsor ID
- GaziU-SBF-EE-02
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1, starting with standard technique | Other | Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.According to block randomization, the 1st researcher will first apply the standard technique (60 seconds pause between palpation and auscultation), 1 minute break will be given, and the 2nd researcher will apply the alternative new technique (no break between palpation and auscultation) on the same person. |
| group 2, starting with alternative new technique | Other | Other: blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used.According to block randomization, Investigator 1 will first apply the alternative new technique (no pause between palpation and auscultation) to the people in the second group, and a 1-minute break will be given. The 2nd researcher will apply the standard technique (60 seconds break between palpation and auscultation) on the same person. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- has a chronic disease,
- taking medication that affects the cardiovascular or circulatory system,
- wants to leave the study at any stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | group 1, starting with standard technique, group 2, starting with alternative new technique |
Primary outcome
blood pressure measurement list
Time frame: approximately 12 weeks from the start of measurements until reporting.
This form will record the participant's systolic and diastolic blood pressure measured with the standard technique and the alternative new technique.
1 secondary outcome
blood pressure measurement time
Time frame: approximately 12 weeks from the start of measurements until reporting.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evrim Eyikara principal investigator
doctor research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood pressure measurement starting with standard technique or alternative new technique. manual sphygmomanometer will be used. in people with Healthy, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure measurement list (time frame: approximately 12 weeks from the start of measurements until reporting.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.