HypotensionNCT06911593
Arterial Stiffness and Hemodynamics in Cardiac Surgery
An observational study of Hypotension and Anesthesia-Induced Hypotension, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: Hypotension during the induction of anesthesia is a significant clinical condition associated with increased perioperative morbidity and mortality. This study aims to evaluate whether hypotension occurring during anesthesia induction can be predicted using arterial stiffness and stiffness index parameters… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypotension, Anesthesia-Induced Hypotension, Arterial Stiffness
- What is being tested?
- Doppler ultrasonography
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 1 Sep 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing open heart surgery
Who may be able to join
- Patients aged between 18 and 85 who underwent elective cardiac surgery
Who cannot join
- Arrhythmia
- End-stage renal failure on dialysis
- Left ventricular ejection fraction <35%
- Reoperation
- Emergency surgery
- Body mass index >40
- Missing data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship of Arterial Stiffness Value With Hemodynamic Parameters in Patients Undergoing Cardiac Surgery
Background:
Hypotension during the induction of anesthesia is a significant clinical condition associated with increased perioperative morbidity and mortality. This study aims to evaluate whether hypotension occurring during anesthesia induction can be predicted using arterial stiffness and stiffness index parameters measured by ultrasonography. Additionally, the study investigates potential associations between arterial stiffness parameters and intraoperative hemodynamic variables, vasoactive drug use, length of stay in the hospital and intensive care unit (ICU), and mortality.
Read more
Methods:
This prospective study was conducted in patients scheduled for elective open cardiac surgery. The predictive value of arterial stiffness, measured by ultrasonography, for identifying hypotension during anesthesia induction was assessed. Carotid-femoral pulse wave velocity (PWV) and stiffness index (β index) were used as indicators of arterial stiffness.
Read the detailed description
Background:
Hypotension during anesthesia induction is a serious clinical condition that may lead to adverse perioperative outcomes such as myocardial ischemia, renal hypoperfusion, and neurological complications. In cardiac surgery, hypotension during induction can compromise myocardial perfusion and increase the risk of ischemic events. In patients with significant coronary artery disease, a sudden drop in systemic blood pressure can reduce coronary perfusion pressure, potentially resulting in left ventricular dysfunction and hemodynamic instability. Therefore, careful hemodynamic management and appropriate use of vasopressors during anesthesia induction are critical to improving perioperative outcomes in open cardiac surgery.
Arterial stiffness refers to the reduced elasticity of arterial walls due to loss of elastic tissue. It increases with age and is associated with a higher risk of cardiovascular disease. Arterial stiffness can be assessed using ultrasonography (USG) or applanation tonometry. Ultrasonographic pulse wave velocity (PWV) measurements are comparable to those obtained via tonometry. Arterial stiffness has become nearly synonymous with PWV, but research on stiffness index and ultrasonographic stiffness measurements remains limited. The predictive role of arterial stiffness in anesthesia-induced hypotension has not been adequately evaluated. This study was designed to address this gap by evaluating whether arterial stiffness and stiffness index measured by USG can predict hypotension during anesthesia induction. Exploratory analyses also examined associations with intraoperative hemodynamic changes, vasoactive drug use, ICU and hospital stay, and mortality.
Methods:
This prospective study was conducted between October 1, 2022, and May 1, 2023, at a university hospital. Ethical approval was obtained from the institutional review board. Patients scheduled for elective cardiac surgery were evaluated. Arterial stiffness and stiffness index values measured by ultrasonography, along with intraoperative and postoperative clinical data, were analyzed. Informed consent was obtained from all participants.
Participants:
Patients aged 18-85 years scheduled for elective cardiac surgery were included. Exclusion criteria included arrhythmia, end-stage renal disease, left ventricular ejection fraction <35%, reoperation, emergency surgery, body mass index >40 kg/m², and incomplete data. Upon arrival in the operating room, standard monitoring was initiated, including ECG, SpO₂, and invasive arterial pressure via radial artery cannulation under local anesthesia. All arterial stiffness measurements were performed by a single clinician after sedation with midazolam and fentanyl. Measurements were conducted in the supine position, followed by anesthesia induction and central venous catheterization. Hemodynamic parameters, hypotension episodes, and vasoactive agent use were recorded throughout the surgical procedure. After surgery, participants were transferred to the intensive care unit.
Measurements - Pulse Wave Velocity (PWV):
A 3-lead ECG was connected to the patient. Measurements were taken in the supine position with the head turned to the left. A sector probe was placed at the bifurcation of the right sternocleidomastoid muscle to visualize Doppler waveforms of the carotid artery. A linear probe was used to measure maximum and minimum diameters of the carotid artery. The femoral artery was imaged below the inguinal ligament. Doppler signals were recorded from both sites simultaneously with ECG. The time delay between the ECG R-wave and the start of the Doppler waveform was measured across three cardiac cycles and averaged. The distance between the measurement points was divided by the delay time to calculate PWV (m/s). This value represented arterial stiffness.
The stiffness index (β) was calculated using the maximum and minimum diameters of the carotid artery and systolic/diastolic blood pressure values:
β = [ln(Systolic BP / Diastolic BP)] / [(Systolic Diameter - Diastolic Diameter) / Diastolic Diameter] The vasoactive inotropic score (VIS) was used to assess the degree of vasopressor and inotropic support. A VIS ≥10 is considered an independent risk factor for increased morbidity and mortality.
Data Collection:
Baseline systolic, diastolic, and mean arterial pressures and heart rate values were recorded pre-induction, pre-intubation, and within the first 10 minutes post-intubation. Additional hemodynamic parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV), and central venous pressure (CVP) were also collected. Intraoperative hypotension was defined as systolic arterial pressure (SAP) <90 mmHg. Thresholds of <80 mmHg and <70 mmHg were also explored. The types and doses of vasoactive and inotropic agents used during surgery, including during cardiopulmonary bypass, were recorded. VIS values were calculated and analyzed in relation to arterial stiffness parameters.
- Being tested
- Doppler ultrasonography
- Keywords
- Arterial stiffness, Cardiac surgery, Doppler ultrasonography, Pulse wave velocity, Stiffness index
- Medical subject headings
- Hypotension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasonographyDiagnostic test
The delay time was determined as the time difference between the onset of the Doppler waveform and the R-wave on the electrocardiogram(ECG) of the USG device. The distance between the carotid and femoral arteries, where imaging was performed, was then measured. This distance was divided by the delay time to calculate the carotid-femoral pulse wave velocity(PWV) in meters per second, which was considered a measure of arterial stiffness.
| Study group | Role | What they receive |
|---|---|---|
| Single group | In our study, a single group was analyzed without comparisons to another group. Ultrasonographic measurements were performed within a single patient cohort. Receives: Diagnostic Test: Doppler ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid-femoral Pulse Wave Velocity (PWV)
PWV will be calculated by dividing the distance between the carotid and femoral measurement sites by the time delay between the R-wave on the ECG and the onset of the Doppler waveform. Measurements will be obtained via Doppler ultrasonography prior to anesthesia induction. The average of three consecutive cardiac cycles will be used to ensure accuracy.
Unit of Measure:
Meters per second (m/s)
Measured: Baseline (prior to anesthesia induction)
Secondary outcomes (4)
Stiffness Index (β)
The stiffness index (β) will be calculated using the following formula:
β = [ln(Systolic BP / Diastolic BP)] / [(Systolic Diameter - Diastolic Diameter) / Diastolic Diameter] This calculation will be based on carotid artery diameters measured by ultrasound and non-invasive blood pressure measurements.
Unit of Measure:
Unitless ratio
Measured: Within the first 15 minutes following anesthesia induction
Vasoactive Inotropic Score (VIS)
VIS will be calculated to quantify the amount of vasopressor and inotropic support administered during surgery. The formula is as follows:
VIS = Dopamine (mcg/kg/min) + Dobutamine (mcg/kg/min) + 100 × Epinephrine (mcg/kg/min) + 100 × Norepinephrine (mcg/kg/min) + 10 × Milrinone (mcg/kg/min) + 10,000 × Vasopressin (units/kg/min)
Unit of Measure:
Numeric score
Measured: From anesthesia induction until the end of surgery (up to 6 hours)
Length of Stay in the Intensive Care Unit (ICU)
The number of days each participant spends in the intensive care unit (ICU) following surgery will be recorded. This outcome will be used to explore potential associations with arterial stiffness parameters.
Unit of Measure:
Days
Measured: From admission to the ICU until discharge from the ICU (up to 14 days)
Length of Stay in the Hospital
The total number of days each participant remains hospitalized after surgery will be recorded. This exploratory outcome will be analyzed in relation to arterial stiffness and stiffness index values.
Unit of Measure:
Days
Measured: From the day of surgery until hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Oct 2022
- Primary completion1 May 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Necmettin Erbakan University
- Responsible party
- Principal investigator, Mustafa Aydemir, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911593
- Sponsor's protocol ID
- 2022/3982
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Mustafa Aydemir Medical Doctor, Necmettin Erbakan University, Medical School, Department of Anesthesiology and Reanimation, Konya, Turkey drmustafaaydemir02@gmail.com ORCID: orcid.org/0000-0002-6289-7031
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Arterial Stiffness Value With Hemodynamic Parameters in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06911593
- Acronym / sponsor ID
- 2022/3982
- Keywords
- Arterial stiffness, Cardiac surgery, Doppler ultrasonography, Pulse wave velocity, Stiffness index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Collaborators
- Necmettin Erbakan University
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 4 Apr 2025 (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.
Background:
Hypotension during the induction of anesthesia is a significant clinical condition associated with increased perioperative morbidity and mortality. This study aims to evaluate whether hypotension occurring during anesthesia induction can be predicted using arterial stiffness and stiffness index parameters measured by ultrasonography. Additionally, the study investigates potential associations between arterial stiffness parameters and intraoperative hemodynamic variables, vasoactive drug use, length of stay in the hospital and intensive care unit (ICU), and mortality.
Methods:
This prospective study was conducted in patients scheduled for elective open cardiac surgery. The predictive value of arterial stiffness, measured by ultrasonography, for identifying hypotension during anesthesia induction was assessed. Carotid-femoral pulse wave velocity (PWV) and stiffness index (β index) were used as indicators of arterial stiffness.
Detailed description
Background:
Hypotension during anesthesia induction is a serious clinical condition that may lead to adverse perioperative outcomes such as myocardial ischemia, renal hypoperfusion, and neurological complications. In cardiac surgery, hypotension during induction can compromise myocardial perfusion and increase the risk of ischemic events. In patients with significant coronary artery disease, a sudden drop in systemic blood pressure can reduce coronary perfusion pressure, potentially resulting in left ventricular dysfunction and hemodynamic instability. Therefore, careful hemodynamic management and appropriate use of vasopressors during anesthesia induction are critical to improving perioperative outcomes in open cardiac surgery.
Arterial stiffness refers to the reduced elasticity of arterial walls due to loss of elastic tissue. It increases with age and is associated with a higher risk of cardiovascular disease. Arterial stiffness can be assessed using ultrasonography (USG) or applanation tonometry. Ultrasonographic pulse wave velocity (PWV) measurements are comparable to those obtained via tonometry. Arterial stiffness has become nearly synonymous with PWV, but research on stiffness index and ultrasonographic stiffness measurements remains limited. The predictive role of arterial stiffness in anesthesia-induced hypotension has not been adequately evaluated. This study was designed to address this gap by evaluating whether arterial stiffness and stiffness index measured by USG can predict hypotension during anesthesia induction. Exploratory analyses also examined associations with intraoperative hemodynamic changes, vasoactive drug use, ICU and hospital stay, and mortality.
Methods:
This prospective study was conducted between October 1, 2022, and May 1, 2023, at a university hospital. Ethical approval was obtained from the institutional review board. Patients scheduled for elective cardiac surgery were evaluated. Arterial stiffness and stiffness index values measured by ultrasonography, along with intraoperative and postoperative clinical data, were analyzed. Informed consent was obtained from all participants.
Participants:
Patients aged 18-85 years scheduled for elective cardiac surgery were included. Exclusion criteria included arrhythmia, end-stage renal disease, left ventricular ejection fraction <35%, reoperation, emergency surgery, body mass index >40 kg/m², and incomplete data. Upon arrival in the operating room, standard monitoring was initiated, including ECG, SpO₂, and invasive arterial pressure via radial artery cannulation under local anesthesia. All arterial stiffness measurements were performed by a single clinician after sedation with midazolam and fentanyl. Measurements were conducted in the supine position, followed by anesthesia induction and central venous catheterization. Hemodynamic parameters, hypotension episodes, and vasoactive agent use were recorded throughout the surgical procedure. After surgery, participants were transferred to the intensive care unit.
Measurements - Pulse Wave Velocity (PWV):
A 3-lead ECG was connected to the patient. Measurements were taken in the supine position with the head turned to the left. A sector probe was placed at the bifurcation of the right sternocleidomastoid muscle to visualize Doppler waveforms of the carotid artery. A linear probe was used to measure maximum and minimum diameters of the carotid artery. The femoral artery was imaged below the inguinal ligament. Doppler signals were recorded from both sites simultaneously with ECG. The time delay between the ECG R-wave and the start of the Doppler waveform was measured across three cardiac cycles and averaged. The distance between the measurement points was divided by the delay time to calculate PWV (m/s). This value represented arterial stiffness.
The stiffness index (β) was calculated using the maximum and minimum diameters of the carotid artery and systolic/diastolic blood pressure values:
β = [ln(Systolic BP / Diastolic BP)] / [(Systolic Diameter - Diastolic Diameter) / Diastolic Diameter] The vasoactive inotropic score (VIS) was used to assess the degree of vasopressor and inotropic support. A VIS ≥10 is considered an independent risk factor for increased morbidity and mortality.
Data Collection:
Baseline systolic, diastolic, and mean arterial pressures and heart rate values were recorded pre-induction, pre-intubation, and within the first 10 minutes post-intubation. Additional hemodynamic parameters such as systolic pressure variation (SPV), pulse pressure variation (PPV), and central venous pressure (CVP) were also collected. Intraoperative hypotension was defined as systolic arterial pressure (SAP) <90 mmHg. Thresholds of <80 mmHg and <70 mmHg were also explored. The types and doses of vasoactive and inotropic agents used during surgery, including during cardiopulmonary bypass, were recorded. VIS values were calculated and analyzed in relation to arterial stiffness parameters.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Diagnostic Test: Doppler ultrasonographyIn our study, a single group was analyzed without comparisons to another group. Ultrasonographic measurements were performed within a single patient cohort. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing open heart surgery
Key inclusion criteria (1 listed)
- Patients aged between 18 and 85 who underwent elective cardiac surgery
Key exclusion criteria (7 listed)
- Arrhythmia
- End-stage renal failure on dialysis
- Left ventricular ejection fraction <35%
- Reoperation
- Emergency surgery
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 |
|---|---|---|
| Doppler ultrasonographyThe delay time was determined as the time difference between the onset of the Doppler waveform and the R-wave on the electrocardiogram(ECG) of the USG device. The distance between the carotid and femoral arteries, where imaging was performed, was then measured. This distance was divided by the delay time to calculate the carotid-femoral pulse wave velocity(PWV) in meters per second, which was considered a measure of arterial stiffness. | Diagnostic test | Single group |
Primary outcome
Carotid-femoral Pulse Wave Velocity (PWV)
Time frame: Baseline (prior to anesthesia induction)
PWV will be calculated by dividing the distance between the carotid and femoral measurement sites by the time delay between the R-wave on the ECG and the onset of the Doppler waveform. Measurements will be obtained via Doppler ultrasonography prior to anesthesia induction. The average of three consecutive cardiac cycles will be used to ensure accuracy. Unit of Measure: Meters per second (m/s)
4 secondary outcomes
Stiffness Index (β)
Time frame: Within the first 15 minutes following anesthesia induction
Vasoactive Inotropic Score (VIS)
Time frame: From anesthesia induction until the end of surgery (up to 6 hours)
Length of Stay in the Intensive Care Unit (ICU)
Time frame: From admission to the ICU until discharge from the ICU (up to 14 days)
Length of Stay in the Hospital
Time frame: From the day of surgery until hospital discharge (up to 30 days)
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 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Mustafa Aydemir Medical Doctor, Necmettin Erbakan University, Medical School, Department of Anesthesiology and Reanimation, Konya, Turkey drmustafaaydemir02@gmail.com ORCID: orcid.org/0000-0002-6289-7031
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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 Hypotension and Anesthesia-Induced Hypotension, run by Konya City Hospital 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 1 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 4 Apr 2025. 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?
Carotid-femoral Pulse Wave Velocity (PWV) (time frame: Baseline (prior to anesthesia induction)). 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 4 Apr 2025.