- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07488182
Preoperative Carotid Doppler Ultrasound Parameters for Prediction of Post-Induction Hypotension in Elective Non-Cardiac Surgery
The Value of Preoperative Carotid Doppler Ultrasonography Parameters in Predicting Post-Induction Hypotension in Patients Undergoing Elective Non-Cardiac Surgery
Study Overview
Status
Detailed Description
Post-induction hypotension (PIH) is a common hemodynamic complication during the induction of general anesthesia and is associated with increased risk of perioperative morbidity and mortality. Identifying patients at risk of developing hypotension before anesthesia induction may allow anesthesiologists to implement preventive strategies and optimize perioperative hemodynamic management.
Traditional static hemodynamic parameters are often insufficient to accurately assess intravascular volume status and cardiovascular reserve. Doppler ultrasound-based measurements have emerged as useful non-invasive tools for evaluating cardiovascular dynamics. Carotid Doppler ultrasonography, in particular, allows rapid bedside assessment of hemodynamic parameters such as carotid velocity-time integral (carotid VTI) and corrected carotid flow time (ccFT), which may reflect changes in stroke volume and preload responsiveness.
This prospective observational study aims to evaluate the ability of preoperative carotid Doppler parameters, including carotid VTI and corrected carotid flow time (ccFT), to predict the development of post-induction hypotension in adult patients undergoing elective non-cardiac surgery under general anesthesia. Carotid Doppler measurements will be performed during the preoperative period, and anesthetic induction will be conducted in accordance with the study protocol under standard monitoring conditions. Hemodynamic parameters will be recorded during the induction period, and the occurrence of post-induction hypotension will be documented.
The primary objective of this study is to determine the predictive performance of carotid VTI and corrected carotid flow time for post-induction hypotension. Secondary analyses will explore the relationship between Doppler-derived hemodynamic parameters and perioperative hemodynamic changes. The findings of this study may contribute to improving perioperative risk stratification and guiding individualized hemodynamic management strategies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Engin Kılınç, medical doctor
- Phone Number: 00 90 332 223 60 00
- Email: enginkilinc96@gmail.com
Study Locations
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Konya, Turkey (Türkiye)
- Necmettin Erbakan University
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Contact:
- Engin Kılınç, medical doctor
- Phone Number: 00 90 332 223 60 00
- Email: enginkilinc96@gmail.com
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Sub-Investigator:
- Engin Kılınç, Medical Doctor
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Principal Investigator:
- SULE ARICAN, Assoc. Prof.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18-65 years
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective non-cardiac surgery under general anesthesia
Planned endotracheal intubation
Ability to provide written informed consent
Exclusion Criteria:
Refusal to participate in the study
Planned emergency surgery
Planned cardiac surgery
Presence of carotid artery stenosis greater than 50%
Moderate to severe valvular heart disease
Presence of atrial fibrillation or significant arrhythmia
Advanced heart failure
Preoperative hypotension or hemodynamic instability
Inability to obtain reliable ultrasonographic measurements
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Elective Non-Cardiac Surgery Patients
Patients undergoing elective non-cardiac surgery will be prospectively enrolled.
Preoperative carotid Doppler ultrasonography parameters, including carotid velocity time integral (VTI) and corrected carotid flow time (ccFT), will be measured before anesthesia induction.
No intervention will be applied as part of the study protocol.
Patients will be followed for the occurrence of post-induction hypotension after standardized anesthesia induction.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-induction hypotension
Time Frame: From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.
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Occurrence of post-induction hypotension after anesthesia induction, defined as either a decrease in mean arterial pressure (MAP) of ≥30% from baseline or a MAP <65 mmHg sustained for at least 1 minute.
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From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Predictive performance of carotid Doppler parameters
Time Frame: From the initiation of anesthetic induction until 10 minutes after tracheal intubation or until surgical incision, whichever occurs first.
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Diagnostic accuracy of preoperative carotid Doppler parameters (carotid VTI and corrected carotid flow time [ccFT]) for predicting post-induction hypotension, including area under the receiver operating characteristic curve (AUC), sensitivity, specificity, and optimal cut-off values.
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From the initiation of anesthetic induction until 10 minutes after tracheal intubation or until surgical incision, whichever occurs first.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686.
- Cheong I, Otero Castro V, Sosa FA, Tort Oribe B, Fruchtenicht MF, Tamagnone FM, Merlo PM. Passive leg raising test using the carotid flow velocity-time integral to predict fluid responsiveness. J Ultrasound. 2024 Mar;27(1):97-104. doi: 10.1007/s40477-023-00824-1. Epub 2023 Sep 5.
- Blanco P
- Cheong I, Otero Castro V, Sosa FA, Tort Oribe B, Merlo PM, Tamagnone FM. Carotid flow as a surrogate of the left ventricular stroke volume. J Clin Monit Comput. 2023 Apr;37(2):661-667. doi: 10.1007/s10877-022-00938-7. Epub 2022 Nov 18.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026/6334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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