Consistency of Carotid Doppler Blood Flow and Thermodilution Technique

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944146

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Behavioral: passive leg raising Drug: Dobutamine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan hospital Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

Shanghai Zhongshan Hospital

Investigators

Study Chair: Zhe Luo, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shanghai Zhongshan Hospital

ClinicalTrials.gov Identifier:

NCT05944146

Other Study ID Numbers:

Cracard

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Shanghai Zhongshan Hospital

carotid doppler; hemodynamic

Additional relevant MeSH terms:

Dobutamine

Study Results

No Results Posted as of Jul 13, 2023