Post Induction HypotensionNCT07488182
Preoperative Carotid Doppler Ultrasound Parameters for Prediction of Post-Induction Hypotension in Elective Non-Cardiac Surgery
An observational study of Post Induction Hypotension and Postoperative Morbidity, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Induction Hypotension, Postoperative Morbidity
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective non-cardiac surgery under general anesthesia will be included in this study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Advanced heart failure
- Preoperative hypotension or hemodynamic instability
- Inability to obtain reliable ultrasonographic measurements
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya
Engin Kılınç, medical doctor, 00 90 332 223 60 00, enginkilinc96@gmail.com
Engin Kılınç, Medical Doctor
About this study
Official title: The Value of Preoperative Carotid Doppler Ultrasonography Parameters in Predicting Post-Induction Hypotension in Patients Undergoing Elective Non-Cardiac Surgery
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.
Read the 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.
- Keywords
- Doppler Ultrasound, Velocity Time Integral, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction hypotension
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.
Measured: From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.
Secondary outcomes (1)
Predictive performance of carotid Doppler parameters
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.
Measured: From the initiation of anesthetic induction until 10 minutes after tracheal intubation or until surgical incision, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Induction HypotensionStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞULE ARICAN, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488182
- Sponsor's protocol ID
- 2026/6334
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25929547Blanco 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.
PubMed 32318842Cheong 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.
PubMed 37668901Cheong 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.
PubMed 36399216
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Preoperative Carotid Doppler Ultrasonography Parameters in Predicting Post-Induction Hypotension in Patients Undergoing Elective Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07488182
- Acronym / sponsor ID
- 2026/6334
- Keywords
- Doppler Ultrasound, Velocity Time Integral, Anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Mar 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective non-cardiac surgery under general anesthesia will be included in this study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-induction hypotension
Time frame: From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Background: PubMed 25929547Mascha 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.
- Background: PubMed 32318842Blanco 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.
- Background: PubMed 37668901Cheong 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.
- Background: PubMed 36399216Cheong 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.
- Individual participant dataSharing planned: No
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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.
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 Post Induction Hypotension and Postoperative Morbidity, run by Necmettin Erbakan University 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Engin Kılınç, Medical Doctor (00 90 332 223 60 00, enginkilinc96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction hypotension (time frame: From anesthesia induction until 10 minutes after tracheal intubation or until the start of surgery, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07488182, which also lists 4 linked publications.
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 23 Mar 2026.