Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05944146
• Other study ID #: Cracard
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: Shanghai Zhongshan Hospital
• Contact: Guang-wei Hao
• Phone: 02164041990
• Email: hao.guangwei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Behavioral:
• passive leg raising
transfer a patient from semi-recumbent position to supine position with a 45° leg lifting

Drug:
• Dobutamine
infusion dobutamine

Locations

Country	Name	City	State
China	Zhongshan hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

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