Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

The Consistency of Tracking Changes of Cardiac Output by Carotid Doppler Blood Flow and Thermodilution Technique in Cardiac Surgery Patients

Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Behavioral: passive leg raising; Drug: Dobutamine

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guang-wei Hao; Phone Number: 02164041990; Email: hao.guangwei@zs-hospital.sh.cn
• Study Contact Backup: Name: Guo-wei Tu; Phone Number: 02164041990; Email: tu.guowei@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Contact: Guang-wei Hao; Phone Number: 02164041990; Email: haoguangwei@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adult cardiac surgery patients
• with thermodilution technique monitoring
• mechanical ventilation

Exclusion Criteria:

• life threatening arrhythmia
• severe valve regurgitation
• left ventricular ejection fraction less than 30%
• patients with mechanical circulatory support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cardiac surgery patients with thermodilution technique monitoring	Behavioral: passive leg raising; transfer a patient from semi-recumbent position to supine position with a 45° leg lifting; Drug: Dobutamine; infusion dobutamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac output by thermodilution method	measuring cardiac output using thermodilution method	5 minutes after the patients was sedated
cardiac output by continuous carotid doppler blood flow	measuring cardiac output using continuous carotid doppler blood flow	5minutes after the patients was sedated
cardiac output by thermodilution method	measuring cardiac output using thermodilution method	2 minutes after passive leg raising
cardiac output by continuous carotid doppler blood flow	measuring cardiac output using continuous carotid doppler blood flow	2 minutes after passive leg raising
cardiac output by thermodilution method	measuring cardiac output using thermodilution method	15 minutes after termination of passive leg raising
cardiac output by continuous carotid doppler blood flow	measuring cardiac output using continuous carotid doppler blood flow	15 minutes after termination of passive leg raising
cardiac output by thermodilution method	measuring cardiac output using thermodilution method	30 minutes after dobutamine infusion
cardiac output by continuous carotid doppler blood flow	measuring cardiac output using continuous carotid doppler blood flow	30 minutes after dobutamine infusion

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Zhe Luo, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 12, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 12, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: carotid doppler; hemodynamic
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: Cracard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No