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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • NecmettinEU

    Konya, 42200

Other trials in Turkey (Türkiye)

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 groups in NCT06911593
Study groupRoleWhat they receive
Single groupIn 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.

  1. 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)
  1. 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

  2. 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)

  3. 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)

  4. 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.

  1. First posted4 Apr 2025
  2. Study start1 Oct 2022
  3. Primary completion1 May 2023
  4. Study completion1 Sep 2023

Resources

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)
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

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.

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