Fluid ResponsivenessNCT07245485
Fluid Responsiveness With Passive Leg Raising in Patients Undergoing Coronary Artery Bypass Surgery
An observational study of Fluid Responsiveness and Passive Leg Raising, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the reliability of corrected carotid flow time (ccFT) and the percentage change in peak flow velocity (ΔVpeak), as non-invasive methods for assessing fluid responsiveness using the passive leg raising (PLR) test in patients undergoing coronary bypass surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fluid Responsiveness, Passive Leg Raising, Corrected Carotid Flow Time
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 14 Feb 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room
Who may be able to join
- A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room of the Ministry of Health Ankara Bilkent City Hospital will be included in the study.
- The volunteers to be included will be patients aged between 18 and 80 years, evaluated as ASA class II-III according to the American Society of Anesthesiologists (ASA) classification.
Who cannot join
- Patients who do not wish to participate in the study
- Patients younger than 18 or older than 80 years
- Patients with an ASA score greater than III
- Patients with BMI > 35
- Patients with EF < 40%
- Patients with atrial fibrillation
Show all 15Show fewer
- Patients with severe valvular stenosis or insufficiency
- Patients with right ventricular dysfunction
- Patients with carotid artery stenosis
- Patients with a history of cerebrovascular accident or transient ischemic attack
- Patients with increased intra-abdominal or intracranial pressure
- Patients with glaucoma
- Patients with severe renal or hepatic disease
- Patients who develop hemodynamic instability during the perioperative period
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya
Ankara, Çankaya, 06800
About this study
Official title: Fluid Responsiveness in Coronary Artery Bypass Surgery: The Role of Carotid Artery Ultrasound and Passive Leg Raising Maneuver
The aim of this study is to investigate the reliability of corrected carotid flow time (ccFT) and the percentage change in peak flow velocity (ΔVpeak), as non-invasive methods for assessing fluid responsiveness using the passive leg raising (PLR) test in patients undergoing coronary bypass surgery.
Read the detailed description
This study is a single-center, prospective, and observational research. After obtaining approval from the ethics committee, 50 patients scheduled for elective coronary artery bypass surgery under general anesthesia at the Cardiovascular Surgery operating room of the Ministry of Health Ankara City Hospital will be included in the study. The study is designed as a single-center, prospective, and observational trial.
Patient data including weight, height, age, gender, BMI (body mass index), ASA classification, left ventricular ejection fraction, comorbidities, and medications will be recorded. Anesthesia induction and management will be performed in accordance with the routine practice of the anesthesia clinic. After the patient is brought to the operating table, in addition to standard hemodynamic monitoring with non-invasive blood pressure (NIBP), 5-lead ECG, and pulse oximetry, bispectral index (BIS), body temperature, and cardiac output monitoring with the Pulsion Flex device will be performed. Parameters measured by the Pulsion Flex device (CI, SVI, SVRI, SVV, PPV, DO2I, dPmx) will be recorded before and after anesthesia induction. General anesthesia will be induced with preoxygenation followed by 0.05 mg/kg midazolam, 1 mg/kg lidocaine, 3 mcg/kg fentanyl, and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.6-0.8 mg/kg rocuronium, and orotracheal intubation will be performed with an appropriate tube. The target BIS value will be maintained within 40-60, and anesthesia will be maintained by adjusting the concentration of volatile anesthetics and remifentanil infusion dose (0.05-0.2 mcg/kg/min) according to hemodynamic parameters.
Ventilation mode and parameters will be set as follows: tidal volume 8 ml/kg based on ideal body weight, respiratory rate adjusted to maintain end-tidal CO₂ between 30-40 mmHg, inspiration/expiration ratio 1:2, positive end-expiratory pressure (PEEP) 5 cmH₂O, and FiO₂ 50%. After Allen's test is performed, radial artery catheterization of the non-dominant hand will be performed for invasive blood pressure monitoring, and a 7 Fr triple-lumen central venous catheter will be inserted into the right internal jugular vein for central venous pressure (CVP) monitoring. These procedures are routinely performed in patients scheduled for open thoracic surgery in our clinic. Preferably, two large-bore peripheral intravenous lines will also be inserted. Measurements will begin once patient preparation is complete, during a hemodynamically stable period, and when spontaneous respiratory effort is absent.
After the patient is placed in a 45-degree head-up semi-sitting position, hemodynamic parameters will be recorded: heart rate (HR, beats/min), systolic arterial pressure (SAP, mmHg), diastolic arterial pressure (DAP, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, and SVV. Corrected carotid flow time (ccFT) and the percentage change in peak velocity (ΔVpeak), measured using Doppler ultrasound, will also be recorded. Ultrasound measurements will be performed with a 4-12 MHz linear probe in vascular mode. With the patient's head tilted 30 degrees to the left, a longitudinal view of the right common carotid artery will be obtained below the lower border of the thyroid cartilage, and measurements will be taken 2 cm proximal to the carotid bifurcation. Doppler will be activated, and the sample volume will be placed at an angle less than 60 degrees in the region with optimal color flow. Flow time will be measured from the beginning of the systolic upstroke to the dicrotic notch.
After one minute of passive leg raising (PLR), hemodynamic parameters as well as ccFT and ΔVpeak will be measured again and recorded. Patients demonstrating a ≥10% increase in CI measured by the Pulsion Flex device after PLR will be classified as fluid responsive, while those without such an increase will be classified as non-responders. The differences in ccFT and ΔVpeak parameters between the two groups will be analyzed.
- Keywords
- Hemodynamic Monitoring, Corrected Carotid Flow Time, Passive Leg Raising
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 |
|---|---|---|
| Study Group | After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.After passive leg raising, ccFT and hemodynamic parameters will be recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic parameters (T0)
After patient monitoring, hemodynamic parameter values will be recorded before anesthesia induction
Measured: before anesthesia induction
hemodynamic parameters (T1)
Hemodynamic parameters will be recorded after anesthesia induction.
Measured: after anesthesia induction
ccFT and Hemodynamic parameters (T3)
After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.
Measured: After the patient is placed in a 45-degree head-up position
ccFT and Hemodynamic Parameters (T4)
After passive leg raising, ccFT and hemodynamic parameters will be recorded.
Measured: After passive leg raising
Secondary outcomes (2)
Delta Vpeak
calculation of Delta Vpeak
Measured: After the patient is placed in a 45-degree head-up position
Delta Vpeak
calculation of Delta Vpeak
Measured: After passive leg raising
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start30 Dec 2025
- Primary completion21 Jan 2026
- Study completion14 Feb 2026
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 Fluid ResponsivenessStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ümit Karadeniz, Professor, Study director, Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245485
- Sponsor's protocol ID
- TABED 1-25-1556
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singla D, Gupta B, Varshney P, Mangla M, Walikar BN, Jamir T. Role of carotid corrected flow time and peak velocity variation in predicting fluid responsiveness: a systematic review and meta-analysis. Korean J Anesthesiol. 2023 Jun;76(3):183-193. doi: 10.4097/kja.22385. Epub 2022 Nov 15.
PubMed 36377330Walker SCD, Lipszyc AC, Kilmurray M, Wilding H, Akhlaghi H. Questioning the Role of Carotid Artery Ultrasound in Assessing Fluid Responsiveness in Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Res Pract. 2024 Apr 27;2024:9102961. doi: 10.1155/2024/9102961. eCollection 2024.
PubMed 38716052Cheong 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 37668901Suresh V, Sethuraman M, Karunakaran J, Koshy T. Fluid responsiveness to passive leg raising in patients with and without coronary artery disease: A prospective observational study. Ann Card Anaesth. 2020 Oct-Dec;23(4):439-446. doi: 10.4103/aca.ACA_73_19.
PubMed 33109801
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness in Coronary Artery Bypass Surgery: The Role of Carotid Artery Ultrasound and Passive Leg Raising Maneuver
- ClinicalTrials.gov ID
- NCT07245485
- Acronym / sponsor ID
- TABED 1-25-1556
- Keywords
- Hemodynamic Monitoring, Corrected Carotid Flow Time, Passive Leg Raising
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 14 Feb 2026 (actual)
- First posted
- 24 Nov 2025 (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.
The aim of this study is to investigate the reliability of corrected carotid flow time (ccFT) and the percentage change in peak flow velocity (ΔVpeak), as non-invasive methods for assessing fluid responsiveness using the passive leg raising (PLR) test in patients undergoing coronary bypass surgery.
Detailed description
This study is a single-center, prospective, and observational research. After obtaining approval from the ethics committee, 50 patients scheduled for elective coronary artery bypass surgery under general anesthesia at the Cardiovascular Surgery operating room of the Ministry of Health Ankara City Hospital will be included in the study. The study is designed as a single-center, prospective, and observational trial.
Patient data including weight, height, age, gender, BMI (body mass index), ASA classification, left ventricular ejection fraction, comorbidities, and medications will be recorded. Anesthesia induction and management will be performed in accordance with the routine practice of the anesthesia clinic. After the patient is brought to the operating table, in addition to standard hemodynamic monitoring with non-invasive blood pressure (NIBP), 5-lead ECG, and pulse oximetry, bispectral index (BIS), body temperature, and cardiac output monitoring with the Pulsion Flex device will be performed. Parameters measured by the Pulsion Flex device (CI, SVI, SVRI, SVV, PPV, DO2I, dPmx) will be recorded before and after anesthesia induction. General anesthesia will be induced with preoxygenation followed by 0.05 mg/kg midazolam, 1 mg/kg lidocaine, 3 mcg/kg fentanyl, and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.6-0.8 mg/kg rocuronium, and orotracheal intubation will be performed with an appropriate tube. The target BIS value will be maintained within 40-60, and anesthesia will be maintained by adjusting the concentration of volatile anesthetics and remifentanil infusion dose (0.05-0.2 mcg/kg/min) according to hemodynamic parameters.
Ventilation mode and parameters will be set as follows: tidal volume 8 ml/kg based on ideal body weight, respiratory rate adjusted to maintain end-tidal CO₂ between 30-40 mmHg, inspiration/expiration ratio 1:2, positive end-expiratory pressure (PEEP) 5 cmH₂O, and FiO₂ 50%. After Allen's test is performed, radial artery catheterization of the non-dominant hand will be performed for invasive blood pressure monitoring, and a 7 Fr triple-lumen central venous catheter will be inserted into the right internal jugular vein for central venous pressure (CVP) monitoring. These procedures are routinely performed in patients scheduled for open thoracic surgery in our clinic. Preferably, two large-bore peripheral intravenous lines will also be inserted. Measurements will begin once patient preparation is complete, during a hemodynamically stable period, and when spontaneous respiratory effort is absent.
After the patient is placed in a 45-degree head-up semi-sitting position, hemodynamic parameters will be recorded: heart rate (HR, beats/min), systolic arterial pressure (SAP, mmHg), diastolic arterial pressure (DAP, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, and SVV. Corrected carotid flow time (ccFT) and the percentage change in peak velocity (ΔVpeak), measured using Doppler ultrasound, will also be recorded. Ultrasound measurements will be performed with a 4-12 MHz linear probe in vascular mode. With the patient's head tilted 30 degrees to the left, a longitudinal view of the right common carotid artery will be obtained below the lower border of the thyroid cartilage, and measurements will be taken 2 cm proximal to the carotid bifurcation. Doppler will be activated, and the sample volume will be placed at an angle less than 60 degrees in the region with optimal color flow. Flow time will be measured from the beginning of the systolic upstroke to the dicrotic notch.
After one minute of passive leg raising (PLR), hemodynamic parameters as well as ccFT and ΔVpeak will be measured again and recorded. Patients demonstrating a ≥10% increase in CI measured by the Pulsion Flex device after PLR will be classified as fluid responsive, while those without such an increase will be classified as non-responders. The differences in ccFT and ΔVpeak parameters between the two groups will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.After passive leg raising, ccFT and hemodynamic parameters will be recorded. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room
Key inclusion criteria (2 listed)
- A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room of the Ministry of Health Ankara Bilkent City Hospital will be included in the study.
- The volunteers to be included will be patients aged between 18 and 80 years, evaluated as ASA class II-III according to the American Society of Anesthesiologists (ASA) classification.
Key exclusion criteria (15 listed)
- Patients who do not wish to participate in the study
- Patients younger than 18 or older than 80 years
- Patients with an ASA score greater than III
- Patients with BMI > 35
- Patients with EF < 40%
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
hemodynamic parameters (T0)
Time frame: before anesthesia induction
After patient monitoring, hemodynamic parameter values will be recorded before anesthesia induction
hemodynamic parameters (T1)
Time frame: after anesthesia induction
Hemodynamic parameters will be recorded after anesthesia induction.
ccFT and Hemodynamic parameters (T3)
Time frame: After the patient is placed in a 45-degree head-up position
After the patient is placed in a 45-degree head-up position, ccFT will be measured and hemodynamic parameters will be recorded.
ccFT and Hemodynamic Parameters (T4)
Time frame: After passive leg raising
After passive leg raising, ccFT and hemodynamic parameters will be recorded.
2 secondary outcomes
Delta Vpeak
Time frame: After the patient is placed in a 45-degree head-up position
Delta Vpeak
Time frame: After passive leg raising
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 36377330Singla D, Gupta B, Varshney P, Mangla M, Walikar BN, Jamir T. Role of carotid corrected flow time and peak velocity variation in predicting fluid responsiveness: a systematic review and meta-analysis. Korean J Anesthesiol. 2023 Jun;76(3):183-193. doi: 10.4097/kja.22385. Epub 2022 Nov 15.
- Background: PubMed 38716052Walker SCD, Lipszyc AC, Kilmurray M, Wilding H, Akhlaghi H. Questioning the Role of Carotid Artery Ultrasound in Assessing Fluid Responsiveness in Critical Illness: A Systematic Review and Meta-Analysis. Crit Care Res Pract. 2024 Apr 27;2024:9102961. doi: 10.1155/2024/9102961. eCollection 2024.
- 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 33109801Suresh V, Sethuraman M, Karunakaran J, Koshy T. Fluid responsiveness to passive leg raising in patients with and without coronary artery disease: A prospective observational study. Ann Card Anaesth. 2020 Oct-Dec;23(4):439-446. doi: 10.4103/aca.ACA_73_19.
- 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. This study is not recruiting at the moment.
Ümit Karadeniz, Professor study director
Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya
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 Fluid Responsiveness and Passive Leg Raising, run by Ankara City Hospital Bilkent 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 2 inclusion and 15 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 20 Feb 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?
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?
hemodynamic parameters (T0) (time frame: before anesthesia induction). The study lists 4 primary outcomes in all. 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 NCT07245485, 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 20 Feb 2026.