Arterial Stiffness and Hemodynamics in Cardiac Surgery

NCT06911593 | Completed DMC

• 1 other identifier: 2022/3982
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypotension; Anesthesia-Induced Hypotension; Arterial Stiffness; Cardiovascular Diseases

Keywords

Arterial stiffness; Cardiac surgery; Doppler ultrasonography; Pulse wave velocity; Stiffness index

Outcome Measures

Primary Outcomes (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)

  Baseline (prior to anesthesia induction)

Secondary Outcomes (4)

• Stiffness Index (β)

  Within the first 15 minutes following anesthesia induction

• Vasoactive Inotropic Score (VIS)

  From anesthesia induction until the end of surgery (up to 6 hours)

• Length of Stay in the Intensive Care Unit (ICU)

  From admission to the ICU until discharge from the ICU (up to 14 days)

• Length of Stay in the Hospital

  From the day of surgery until hospital discharge (up to 30 days)

Study Arms (1)

Single group

In our study, a single group was analyzed without comparisons to another group. Ultrasonographic measurements were performed within a single patient cohort.

Diagnostic Test: Doppler ultrasonography

Interventions

Doppler ultrasonography DIAGNOSTIC_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.

Single group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing open heart surgery

You may qualify if:

• Patients aged between 18 and 85 who underwent elective cardiac surgery

You may not qualify if:

• Arrhythmia
• End-stage renal failure on dialysis
• Left ventricular ejection fraction \<35%
• Reoperation
• Emergency surgery
• Body mass index \>40
• Missing data

Sponsors & Collaborators

• Konya City Hospital: lead
• Necmettin Erbakan University: collaborator

Study Sites (1)

NecmettinEU

Konya, 42200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension; Cardiovascular Diseases

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 4, 2025
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)