Fluid Responsiveness Through the Corrected Carotid Flow Time, Before and After Sternotomy

NCT06967142 | Completed

• 1 other identifier: Corrected Carotid Flow Time
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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 .

Conditions

Coronary Artery Disease

Keywords

corrected carotid flow time; fluid responsiveness

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 hours

Secondary Outcomes (11)

• diastolic arterial blood pressure

  12 hours

• mean arterial blood pressure

  12 hours

• Anaesthesia debpt based on Bispectral İndex

  12 hours

• heart rate

  12 hours

• Systemic vascular resistance

  12 hours

Study Arms (1)

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

Device: Correcte Carotid flow measurement by USG Doppler

Interventions

Correcte Carotid flow measurement by USG Doppler DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• ASA 2-3 patients
• Aged 18-80 years
• Will undergo elective coronary bypass surgery under general anesthesia

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34191254 RESULT

• Lagier 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.

  PMID: 30424770 RESULT

• Watanabe 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.

  PMID: 34856928 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Seda Kurtbeyoğlu, doctor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

• Rahime Güney, doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, doctor

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: May 13, 2025
• Study Start: January 1, 2025
• Primary Completion: February 25, 2025
• Study Completion: February 28, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)