Arterial StiffnessASNCT05155514
Pulse Wave Velocity and Hemodynamic Response During Anesthesia Induction in Hypertensive Patients
An observational study of Arterial Stiffness, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness
- What is being tested?
- Mobil-O-Graph PWA
- Type of treatment
- Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 1 Nov 2020
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All Patients aged 50 and over
Who may be able to join
- According to the American Society of Anesthesiologists (ASA), physical condition I-II,
- Elective otolaryngology surgery with endotracheal intubation planned
- Patients aged 50 and over
Who cannot join
- Hypersensitivity to drugs
- Difficult intubation history
- Diabetes mellitus receiving insulin therapy
- Chronic renal failure or end-stage renal disease
- Heart failure (left ventricular ejection fraction ≤30%)
- Valve disease (moderate to severe)
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Aydin, 09100
About this study
Official title: Comparison of the Relationship Between Preoperatively Measured Pulse Wave Velocity and Hemodynamic Changes During Anesthesia Induction in Hypertensive and Normotensive Patients.
Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness.
In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.
- Conditions
- Arterial Stiffness
- Being tested
- Mobil-O-Graph PWA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobil-O-Graph PWAProcedure or surgery
After resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method.
| Study group | Role | What they receive |
|---|---|---|
| Group H | Hypertension group (Group H):
* Patients with a previous diagnosis of hypertension
* Patients receiving antihypertensive therapy
* Systolic blood pressure (SBP) ≥140mmHg and/or diastolic blood pressure (DBP) ≥90mmHg Receives: Procedure: Mobil-O-Graph PWA | |
| Group N | Normotensive group (Group N): Other non-hypertensive patients Receives: Procedure: Mobil-O-Graph PWA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between hemodynamic values
The difference between the hemodynamic values measured preoperatively and during anesthesia induction was calculated. In addition, ≥20% decrease in preoperative hemodynamic value and/or systolic blood pressure ≤90 mmHg hypotension, ≥20% increased hypertension
Measured: Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155514
- Sponsor's protocol ID
- Arterial stiffness
- Acronym
- AS
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Relationship Between Preoperatively Measured Pulse Wave Velocity and Hemodynamic Changes During Anesthesia Induction in Hypertensive and Normotensive Patients.
- ClinicalTrials.gov ID
- NCT05155514
- Acronym / sponsor ID
- AS / Arterial stiffness
- Conditions
- Arterial Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Dec 2021 (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.
Hypertension is a disease with increasing and serious complications all over the world. In particular, the incidence of hypertension increases with advancing age. Secondary problems that can be caused by hypertension include peripheral vascular diseases, arteriosclerosis, increased risk of heart attack and stroke. It is a measurement of pulse wave velocity (PWV), a non-invasive indicator of arterial stiffness. It is known that sudden hemodynamic changes that occur during the induction of anesthesia cause undesirable intraoperative and postoperative complications. It is known that arterial stiffness, which is more common in elderly patients, causes orthostatic hypotension in particular. For this reason, more hemodynamic instability may be seen in the general anesthesia procedure in elderly patients with increased arterial stiffness.
In our study, we aimed to investigate whether the hemodynamic changes observed during anesthesia induction in hypertensive elderly patients, whom we think have a high pulse wave velocity, are different from normotensive patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group H | – | Procedure: Mobil-O-Graph PWAHypertension group (Group H): * Patients with a previous diagnosis of hypertension * Patients receiving antihypertensive therapy * Systolic blood pressure (SBP) ≥140mmHg and/or diastolic blood pressure (DBP) ≥90mmHg |
| Group N | – | Procedure: Mobil-O-Graph PWANormotensive group (Group N): Other non-hypertensive patients |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All Patients aged 50 and over
Key inclusion criteria (3 listed)
- According to the American Society of Anesthesiologists (ASA), physical condition I-II,
- Elective otolaryngology surgery with endotracheal intubation planned
- Patients aged 50 and over
Key exclusion criteria (7 listed)
- Hypersensitivity to drugs
- Difficult intubation history
- Diabetes mellitus receiving insulin therapy
- Chronic renal failure or end-stage renal disease
- Heart failure (left ventricular ejection fraction ≤30%)
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 |
|---|---|---|
| Mobil-O-Graph PWAAfter resting in a quiet room preoperatively, blood pressure was measured on the right arm using an oscillometric method. | Procedure or surgery | Group H, Group N |
Primary outcome
Difference between hemodynamic values
Time frame: Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation
The difference between the hemodynamic values measured preoperatively and during anesthesia induction was calculated. In addition, ≥20% decrease in preoperative hemodynamic value and/or systolic blood pressure ≤90 mmHg hypotension, ≥20% increased hypertension
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 13 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness, run by Aydin Adnan Menderes 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 3 inclusion and 7 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 13 Dec 2021. 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?
Difference between hemodynamic values (time frame: Basal measurement before induction of anesthesia, then at 1-minute intervals until after endotracheal intubation). 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 13 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.