NCT07245485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2026

Completed
Last Updated

February 20, 2026

Status Verified

January 1, 2026

Enrollment Period

22 days

First QC Date

September 24, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

Hemodynamic MonitoringCorrected Carotid Flow TimePassive Leg Raising

Outcome Measures

Primary Outcomes (4)

  • hemodynamic parameters (T0)

    After patient monitoring, hemodynamic parameter values will be recorded before anesthesia induction

    before anesthesia induction

  • hemodynamic parameters (T1)

    Hemodynamic parameters will be recorded after anesthesia induction.

    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.

    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.

    After passive leg raising

Secondary Outcomes (2)

  • Delta Vpeak

    After the patient is placed in a 45-degree head-up position

  • Delta Vpeak

    After passive leg raising

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 50 patients undergoing elective coronary artery bypass surgery under general anesthesia in the Cardiovascular Surgery operating room

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 36377330BACKGROUND
  • Walker 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.

    PMID: 38716052BACKGROUND
  • Cheong 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.

    PMID: 37668901BACKGROUND
  • Suresh 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.

    PMID: 33109801BACKGROUND

Study Officials

  • Ümit Karadeniz, Professor

    Ankara Bilkent City Hospital Department of Anesthesiology and Reanimation, Ankara, Çankaya

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

November 24, 2025

Study Start

December 30, 2025

Primary Completion

January 21, 2026

Study Completion

February 14, 2026

Last Updated

February 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations