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NCT06967142Completed

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

Source: ClinicalTrials.gov · Last updated 18 May 2025

Brief summary (registry, in English)

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 .

Status (registry)
Completed
Study type
Observational
Enrollment
45 (actual)
First submitted
2 Mar 2025
Start date
1 Jan 2025
Primary completion date
25 Feb 2025
Lead sponsor
Ankara City Hospital Bilkent
NCT number
NCT06967142

What you commit to

  • Study type: Observational
  • Participants enrolled: 45
  • From 1 Jan 2025 to the primary completion date, 25 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with contraindications to anesthetic drugs
  • Patients who experience unexpected intraoperative surgical complications

Other illness

  • Chronic obstructive pulmonary disease (COPD)
  • Bullous lung disease
  • Moderate to severe pulmonary hypertension (PHT)
  • Severe renal or liver disease

Lab values

  • Ejection fraction (EF) \<40%

Age

  • Age \<18 or \>80 years

Other

  • Patients with an ASA score greater than 3
  • BMI \>30
  • Patients who do not wish to participate in the study
  • Right ventricular dysfunction
  • Patients who develop hemodynamic instability in the perioperative period
  • Pregnancy
    • Criteria for Study Termination:
  • Patients who develop hemodynamic instability during LRM

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ankara Bilkent City Hospital
Coordinator of this site? Confirm its status
ÇankayaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.