Coronary Artery DiseaseNCT06967142
Fluid Responsiveness Through the Corrected Carotid Flow Time, Before and After Sternotomy
An observational study of Coronary Artery Disease, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Perioperative fluid management is used to maintain the perfusion of vital organs, prevent hypovolemia, inadequate tissue perfusion, and tissue edema, and cardiovascular complications caused by the infusion of large amounts of blood and blood products. Optimal fluid management improves postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Correcte Carotid flow measurement by USG Doppler
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 28 Feb 2025
- 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: ASA 2-3 patients aged 18-80 years who will undergo elective coronary bypass surgery under general anesthesia in the cardiovascular surgery operating room of Ankara City Hospital.
Who may be able to join
- ASA 2-3 patients
- Aged 18-80 years
- Will undergo elective coronary bypass surgery under general anesthesia
Who cannot join
- Age <18 or >80 years
- Patients with an ASA score greater than 3
- Ejection fraction (EF) <40%
- Patients with contraindications to anesthetic drugs
- BMI >30
- Patients who do not wish to participate in the study
Show all 16Show fewer
- Right ventricular dysfunction
- Chronic obstructive pulmonary disease (COPD)
- Bullous lung disease
- Moderate to severe pulmonary hypertension (PHT)
- Severe renal or liver disease
- Patients who develop hemodynamic instability in the perioperative period
- Pregnancy
- Criteria for Study Termination:
- Patients who develop hemodynamic instability during LRM
- Patients who experience unexpected intraoperative surgical complications
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Çankaya, Ankara, 06800
About this study
Perioperative fluid management is used to maintain the perfusion of vital organs, prevent hypovolemia, inadequate tissue perfusion, and tissue edema, and cardiovascular complications caused by the infusion of large amounts of blood and blood products. Optimal fluid management improves postoperative outcomes. However, excessive or inadequate fluid infusion increases morbidity. Traditional fluid therapy strategies are divided into three groups: liberal fluid therapy, restrictive fluid therapy, and goal-directed therapy (GDT).
Fluid responsiveness refers to a patient's hemodynamic response to intravenous fluid loading and is defined as an increase of 10% or more in stroke volume (SV) or cardiac output (CO). Various parameters are used to assess fluid responsiveness. Static parameters have limited accuracy in predicting fluid responsiveness. Dynamic parameters such as stroke volume variation (SVV), pulse pressure variation (PPV), passive leg raising test (PLR), and end-expiratory occlusion test (EEOT) have been found to be more reliable in assessing fluid responsiveness.
Read more
The pulse contour analysis method (PCA) continuously measures cardiac output by analyzing the arterial pressure waveform. The ProAQT/PulsioFlex system measures cardiac output by analyzing the arterial waveform without requiring calibration.
Lung recruitment maneuvers (LRM) are techniques used in mechanically ventilated patients to prevent atelectasis and improve oxygenation. They have also been shown to assist in assessing fluid responsiveness. LRM methods include sustained inflation (SI), increased PEEP pressure, increased tidal volume, and targeted recruitment. The temporary increase in intrathoracic pressure during LRM can affect stroke volume variation and be used to assess fluid responsiveness.
Corrected carotid flow time (FTc) is a non-invasive parameter calculated by normalizing the systolic ejection time in the carotid artery to heart rate. FTc can be measured using Doppler ultrasound. It is thought that changes in FTc measured during passive leg raising (PLR) or lung recruitment maneuvers (LRM) may help identify fluid-responsive patients, and new studies are being conducted on this topic.
Recent studies suggest that changes in FTc during lung recruitment maneuvers may be a reliable method for assessing fluid responsiveness.
The optimal method for assessing fluid responsiveness during lung-protective ventilation remains unknown. In patients who have undergone sternotomy with an open chest wall, an ideal method for evaluating fluid responsiveness has not yet been determined.
The primary objective of this study is to investigate the usability of changes in corrected carotid flow time induced by lung recruitment maneuvers during protective lung ventilation (6 ml/kg tidal volume) in patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery to evaluate fluid responsiveness. The secondary objective is to determine the correlation between measurements taken before and after sternotomy. This study aims to reduce invasive procedures used for assessing fluid responsiveness and minimize the need for difficult-to-access devices for measurements.
The study was conducted in the Cardiovascular Surgery Operating Room at the Ministry of Health Ankara Bilkent City Hospital. Fifty patients, aged 18-80 years, classified as ASA II-III, who were scheduled for elective coronary artery bypass graft surgery under general anesthesia, were included in the study. Three patients were excluded due to missing data, and two patients were excluded due to hemodynamic instability, leaving 45 patients in total. The study was designed as a single-center, prospective, observational study and was conducted between July 1, 2024, and November 1, 2024.
All patients included in the study were monitored in the same standard way. Heart rate, intra-arterial monitoring, and PulsioFlex monitoring were performed. All patients were given the same induction and anesthesia maintenance. Fluid responsiveness was evaluated by measurements taken at specific intraoperative times. Hemodynamic parameters, including heart rate (HR) (beats/min), central venous pressure (CVP, mmHg), systolic arterial blood pressure (SAB, mmHg), diastolic arterial blood pressure (DAB, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, SVV, and carotid artery FTc, were assessed and recorded six times:
T1:After induction is complete and preparations are made for the surgical procedure, before incision is started T2:Before starting sternotomy, 1 minute after LRM T3:After sternotomy within 5 minutes T4:After sternotomy, LRM is applied when hemodynamic stability is achieved. Measurement is made 1 minute after LRM.
T5:Measurement is made 10 minutes after T4 when hemodynamic parameters are stable.
T6:After the T5 measurement, the patient All measurements were taken at the beginning of surgery, terminated after 12 hours from the induction .
Read the detailed description
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
- Conditions
- Coronary Artery Disease
- Being tested
- Correcte Carotid flow measurement by USG Doppler
- Keywords
- corrected carotid flow time, fluid responsiveness
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Correcte Carotid flow measurement by USG DopplerDevice
Aim of this study is to investigate the usability of changes in corrected carotid flow time induced by lung recruitment maneuvers during protective lung ventilation (6 ml/kg tidal volume) in patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG) to evaluate fluid responsiveness. The secondary objective is to determine the correlation between measurements taken before and after sternotomy. This study aims to reduce invasive procedures used for assessing fluid responsiveness and develop an alternative method to the use of hard-to-access devices for measurements.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study was conducted at the Cardiovascular Surgery Operating Room of the Ministry of Health Ankara Bilkent City Hospital. Fifty patients, aged 18-80 years, classified as ASA II-III, who were scheduled for elective coronary artery bypass graft surgery under general anesthesia, were included in the study. Three patients were excluded due to missing data, and two patients were excluded due to hemodynamic instability, leaving 45 patients in total.
Hemodynamic parameters, including heart rate (HR) (beats/min), central venous pressure (CVP, mmHg), systolic arterial blood pressure (SAB, mmHg), diastolic arterial blood pressure (DAB, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, SVV, and carotid artery FTc, were assessed and recorded six times:
1.before sternotomy and 2.after LRM, 3.after sternotomy and 4.after LRM, 5.before and 6.after fluid loading Receives: Device: Correcte Carotid flow measurement by USG Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected carotid flow time
The corrected carotid flow time (ccFT) was measured using Doppler ultrasound. The USG probe is placed on the carotid artery and the carotid flow wave is recorded.
CFT is the duration from the beginning of the systolic waveform to the dicrotic notch and corrected for heart rate using Wodey's formula to obtain the ccFT in milliseconds (ms): Corrected carotid flow time (ccFT) = carotid flow time + 1.29 (heart rate-60).
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any re
Measured: 12 hours
Systolic arterial blood pressure
Intra-arterial cannulation and monitoring were established before the induction started. Systolic arterial blood pressure was measured and recorded as mmHg. Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Secondary outcomes (11)
diastolic arterial blood pressure
Intra-arterial cannulation and monitoring were established before the induction started. Diastolic arterial blood pressure was measured and recorded as mmHg. Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
mean arterial blood pressure
Intra-arterial cannulation and monitoring were established before the induction started. Mean arterial blood pressure was measured and recorded as mmHg. Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Anaesthesia debpt based on Bispectral İndex
Anesthesia depth was assessed using BIS (bispectral index) monitoring during surgery and recorded . A numeric value is recorded in the range of 0-100.
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
heart rate
ECG monitoring was performed on the patient, and heart rate was recorded as a numeric value per second.
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Systemic vascular resistance
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the SVR (Systemic Vascular Resistance) value was observed as a numeric value dynes/sec/cm-5. (Normal SVR is between 900 and 1440 dynes/sec/cm-5)
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
stroke volume index
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the SVI (stroke volume index) value was observed as a numeric value mL/m2. (Normal SVI is between 35-65mL/m2)
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
cardiac index
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the CI (cardiac index) value was observed as a numeric value L/min/m2. (Normal CI is between 2.6 and 4.2 L/min/m2)
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Pulse Pressure Variation
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the PPV (Pulse Pressure Variation) value was observed as a numeric value mm Hg. Normal PPV is between 40 and 60 mm Hg)
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Stroke Volüme Variation
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the SVV (Stroke Volüme Variation) value was observed as a numeric value of percentage (%). The normal range of SVV under controlled ventilation is less than 10-13%.
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
central venous pressure
The central venous pressure was measured by a central venous catheter placed through internal jugular veins, using a pressure transducer and observed as a numeric value as mmHg. Normal CVP is approximately 2 to 8 mm Hg. Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Oxygen delivery
Hemodynamic monitoring was performed on the patient with PulsionFlex, and the DO2 (Oxygen delivery) value was observed as a numeric value as ml/min/m2. Normal DO2 is approximately 600 ml/min/m2.
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2025
- Primary completion25 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Kurtbeyoğlu, Ankara City Hospital Bilkent
- Investigators
- Seda Kurtbeyoğlu, doctor, Study director, Ankara City Hospital BilkentRahime Güney, doctor, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967142
- Sponsor's protocol ID
- Corrected Carotid Flow Time
- Status last verified
- May 2025
- First submitted
- 2 Mar 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimura A, Suehiro K, Juri T, Tanaka K, Mori T. Changes in corrected carotid flow time induced by recruitment maneuver predict fluid responsiveness in patients undergoing general anesthesia. J Clin Monit Comput. 2022 Aug;36(4):1069-1077. doi: 10.1007/s10877-021-00736-7. Epub 2021 Jun 30.
PubMed 34191254Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.
PubMed 30424770Watanabe R, Suehiro K, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Changes in stroke volume induced by lung recruitment maneuver can predict fluid responsiveness during intraoperative lung-protective ventilation in prone position. BMC Anesthesiol. 2021 Dec 2;21(1):303. doi: 10.1186/s12871-021-01527-y.
PubMed 34856928
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Through the Corrected Carotid Flow Time, Before and After Sternotomy
- ClinicalTrials.gov ID
- NCT06967142
- Acronym / sponsor ID
- Corrected Carotid Flow Time
- Conditions
- Coronary Artery Disease
- Keywords
- corrected carotid flow time, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 May 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.
Perioperative fluid management is used to maintain the perfusion of vital organs, prevent hypovolemia, inadequate tissue perfusion, and tissue edema, and cardiovascular complications caused by the infusion of large amounts of blood and blood products. Optimal fluid management improves postoperative outcomes. However, excessive or inadequate fluid infusion increases morbidity. Traditional fluid therapy strategies are divided into three groups: liberal fluid therapy, restrictive fluid therapy, and goal-directed therapy (GDT).
Fluid responsiveness refers to a patient's hemodynamic response to intravenous fluid loading and is defined as an increase of 10% or more in stroke volume (SV) or cardiac output (CO). Various parameters are used to assess fluid responsiveness. Static parameters have limited accuracy in predicting fluid responsiveness. Dynamic parameters such as stroke volume variation (SVV), pulse pressure variation (PPV), passive leg raising test (PLR), and end-expiratory occlusion test (EEOT) have been found to be more reliable in assessing fluid responsiveness.
The pulse contour analysis method (PCA) continuously measures cardiac output by analyzing the arterial pressure waveform. The ProAQT/PulsioFlex system measures cardiac output by analyzing the arterial waveform without requiring calibration.
Lung recruitment maneuvers (LRM) are techniques used in mechanically ventilated patients to prevent atelectasis and improve oxygenation. They have also been shown to assist in assessing fluid responsiveness. LRM methods include sustained inflation (SI), increased PEEP pressure, increased tidal volume, and targeted recruitment. The temporary increase in intrathoracic pressure during LRM can affect stroke volume variation and be used to assess fluid responsiveness.
Corrected carotid flow time (FTc) is a non-invasive parameter calculated by normalizing the systolic ejection time in the carotid artery to heart rate. FTc can be measured using Doppler ultrasound. It is thought that changes in FTc measured during passive leg raising (PLR) or lung recruitment maneuvers (LRM) may help identify fluid-responsive patients, and new studies are being conducted on this topic.
Recent studies suggest that changes in FTc during lung recruitment maneuvers may be a reliable method for assessing fluid responsiveness.
The optimal method for assessing fluid responsiveness during lung-protective ventilation remains unknown. In patients who have undergone sternotomy with an open chest wall, an ideal method for evaluating fluid responsiveness has not yet been determined.
The primary objective of this study is to investigate the usability of changes in corrected carotid flow time induced by lung recruitment maneuvers during protective lung ventilation (6 ml/kg tidal volume) in patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery to evaluate fluid responsiveness. The secondary objective is to determine the correlation between measurements taken before and after sternotomy. This study aims to reduce invasive procedures used for assessing fluid responsiveness and minimize the need for difficult-to-access devices for measurements.
The study was conducted in the Cardiovascular Surgery Operating Room at the Ministry of Health Ankara Bilkent City Hospital. Fifty patients, aged 18-80 years, classified as ASA II-III, who were scheduled for elective coronary artery bypass graft surgery under general anesthesia, were included in the study. Three patients were excluded due to missing data, and two patients were excluded due to hemodynamic instability, leaving 45 patients in total. The study was designed as a single-center, prospective, observational study and was conducted between July 1, 2024, and November 1, 2024.
All patients included in the study were monitored in the same standard way. Heart rate, intra-arterial monitoring, and PulsioFlex monitoring were performed. All patients were given the same induction and anesthesia maintenance. Fluid responsiveness was evaluated by measurements taken at specific intraoperative times. Hemodynamic parameters, including heart rate (HR) (beats/min), central venous pressure (CVP, mmHg), systolic arterial blood pressure (SAB, mmHg), diastolic arterial blood pressure (DAB, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, SVV, and carotid artery FTc, were assessed and recorded six times:
T1:After induction is complete and preparations are made for the surgical procedure, before incision is started T2:Before starting sternotomy, 1 minute after LRM T3:After sternotomy within 5 minutes T4:After sternotomy, LRM is applied when hemodynamic stability is achieved. Measurement is made 1 minute after LRM.
T5:Measurement is made 10 minutes after T4 when hemodynamic parameters are stable.
T6:After the T5 measurement, the patient All measurements were taken at the beginning of surgery, terminated after 12 hours from the induction .
Detailed description
Measurements will be taken six times:
T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Correcte Carotid flow measurement by USG DopplerThe study was conducted at the Cardiovascular Surgery Operating Room of the Ministry of Health Ankara Bilkent City Hospital. Fifty patients, aged 18-80 years, classified as ASA II-III, who were scheduled for elective coronary artery bypass graft surgery under general anesthesia, were included in the study. Three patients were excluded due to missing data, and two patients were excluded due to hemodynamic instability, leaving 45 patients in total. Hemodynamic parameters, including heart rate (HR) (beats/min), central venous pressure (CVP, mmHg), systolic arterial blood pressure (SAB, mmHg), diastolic arterial blood pressure (DAB, mmHg), mean arterial pressure (MAP, mmHg), stroke volume index (SVI), cardiac index (CI), PPV, SVV, and carotid artery FTc, were assessed and recorded six times: 1.before sternotomy and 2.after LRM, 3.after sternotomy and 4.after LRM, 5.before and 6.after fluid loading |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 2-3 patients aged 18-80 years who will undergo elective coronary bypass surgery under general anesthesia in the cardiovascular surgery operating room of Ankara City Hospital.
Key inclusion criteria (3 listed)
- ASA 2-3 patients
- Aged 18-80 years
- Will undergo elective coronary bypass surgery under general anesthesia
Key exclusion criteria (16 listed)
- Age <18 or >80 years
- Patients with an ASA score greater than 3
- Ejection fraction (EF) <40%
- Patients with contraindications to anesthetic drugs
- BMI >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Correcte Carotid flow measurement by USG DopplerAim of this study is to investigate the usability of changes in corrected carotid flow time induced by lung recruitment maneuvers during protective lung ventilation (6 ml/kg tidal volume) in patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG) to evaluate fluid responsiveness. The secondary objective is to determine the correlation between measurements taken before and after sternotomy. This study aims to reduce invasive procedures used for assessing fluid responsiveness and develop an alternative method to the use of hard-to-access devices for measurements. | Device | Study group |
Primary outcome
corrected carotid flow time
Time frame: 12 hours
The corrected carotid flow time (ccFT) was measured using Doppler ultrasound. The USG probe is placed on the carotid artery and the carotid flow wave is recorded. CFT is the duration from the beginning of the systolic waveform to the dicrotic notch and corrected for heart rate using Wodey's formula to obtain the ccFT in milliseconds (ms): Corrected carotid flow time (ccFT) = carotid flow time + 1.29 (heart rate-60). Measurements will be taken six times: T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any re
Systolic arterial blood pressure
Time frame: 12 hours
Intra-arterial cannulation and monitoring were established before the induction started. Systolic arterial blood pressure was measured and recorded as mmHg. Measurements will be taken six times: T1.Before sternotomy T2.After LRM is performed before sternotomy T3.5 minutes After sternotomy T4.LRM was performed 10 minutes after sternotomy, the recording will be taken within 2 minutes after the LRM is finished T5.Before fluid loading (15 minutes after T4 if hemodynamics are stable) T6.After fluid loading (After the T5 measurement is taken, the fluid loading is done and after the fluid is finished, within 2 minutes T6 measurement is taken) We expect these measurements to be made during the first half of the surgery; if for any reason it takes longer than 12 hours, the patient will be removed from study
11 secondary outcomes
diastolic arterial blood pressure
Time frame: 12 hours
mean arterial blood pressure
Time frame: 12 hours
Anaesthesia debpt based on Bispectral İndex
Time frame: 12 hours
heart rate
Time frame: 12 hours
Systemic vascular resistance
Time frame: 12 hours
stroke volume index
Time frame: 12 hours
cardiac index
Time frame: 12 hours
Pulse Pressure Variation
Time frame: 12 hours
Stroke Volüme Variation
Time frame: 12 hours
central venous pressure
Time frame: 12 hours
Oxygen delivery
Time frame: 12 hours
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 18 May 2025.
- Results publication: PubMed 34191254Kimura A, Suehiro K, Juri T, Tanaka K, Mori T. Changes in corrected carotid flow time induced by recruitment maneuver predict fluid responsiveness in patients undergoing general anesthesia. J Clin Monit Comput. 2022 Aug;36(4):1069-1077. doi: 10.1007/s10877-021-00736-7. Epub 2021 Jun 30.
- Results publication: PubMed 30424770Lagier D, Fischer F, Fornier W, Fellahi JL, Colson P, Cholley B, Jaber S, Baumstarck K, Guidon C; PROVECS investigators and the ARCOTHOVA group. A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial. Trials. 2018 Nov 13;19(1):624. doi: 10.1186/s13063-018-2967-y.
- Results publication: PubMed 34856928Watanabe R, Suehiro K, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Changes in stroke volume induced by lung recruitment maneuver can predict fluid responsiveness during intraoperative lung-protective ventilation in prone position. BMC Anesthesiol. 2021 Dec 2;21(1):303. doi: 10.1186/s12871-021-01527-y.
- 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.
Seda Kurtbeyoğlu, doctor study director
Ankara City Hospital Bilkent
Rahime Güney, doctor principal investigator
Ankara City Hospital Bilkent
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 Coronary Artery Disease, 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 3 inclusion and 16 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 18 May 2025. 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?
corrected carotid flow time (time frame: 12 hours). The study lists 2 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 NCT06967142, which also lists 3 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 18 May 2025.