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Not yet recruiting NCT07488182

Preoperative Carotid Doppler Ultrasound Parameters for Prediction of Post-Induction Hypotension in Elective Non-Cardiac Surgery

Observational Post Induction Hypotension Postoperative Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post Induction Hypotension, Postoperative Morbidity. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Value of Preoperative Carotid Doppler Ultrasonography Parameters in Predicting Post-Induction Hypotension in Patients Undergoing Elective Non-Cardiac Surgery

Overview

This prospective observational study aims to evaluate the predictive value of preoperative carotid Doppler ultrasound parameters, including carotid velocity-time integral (carotid VTI) and corrected carotid flow time (ccFT), for post-induction hypotension in adult patients undergoing elective non-cardiac surgery under general anesthesia. Hemodynamic instability during anesthesia induction is a common and clinically important problem associated with adverse perioperative outcomes. Carotid Doppler ultrasonography provides a rapid and non-invasive method for assessing hemodynamic status at the bedside. In this study, carotid Doppler measurements will be performed in the preoperative period and their association with post-induction hypotension will be analyzed. The results of this study may help identify patients at risk for hypotension and improve perioperative hemodynamic management.

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.

Primary outcome measures

  • Post-induction hypotension [Time frame: From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Necmettin Erbakan University — Konya

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. PMID 25929547
  • Blanco P. Rationale for using the velocity-time integral and the minute distance for assessing the stroke volume and cardiac output in point-of-care settings. Ultrasound J. 2020 Apr 21;12(1):21. doi: 10.1186/s13089-020-00170-x. PMID 32318842
  • 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. PMID 37668901
  • 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. PMID 36399216

Identifiers

NCT: NCT07488182 · 2026/6334

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗