Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Pulmonary Arterial Hypertension Clinical Trial

Official title:

The Consistency of Cardiac Output Measured by Electrical Cardiometry and Pulmonary Artery Catheter in Cardiac Surgery Patients With Pulmonary Arterial Hypertension or Right Heart Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587400
• Other study ID #: COMEEC
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Zhe Luo, PhD
• Phone: 02164041990
• Email: luo.zhe[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, the gold standard method to estimate CO in patients with PAH or RV dysfunction is pulmonary artery catheter (PAC), however, the invasiveness and complexity of PAC has limited its usefulness in many clinical scenarios. By measuring the thoracic electrical bioimpedance, electrical cardiometry (EC) 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, in patients with pulmonary arterial hypertension (PAH) and/or right ventricular (RV) dysfunction, few study has been reported. The aim of this study is to evaluate the agreement between CO measured by PAC as the referenced method and CO measured by EC technique in patients with PAH and/or RV dysfunction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 199
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult cardiac surgery patients
• pulmonary artery hypertension and/or right heart dysfunction
• 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

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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

Drug:
• dobutamine test
infusion dobutamine
• inhaled nitric oxide
nitric oxide inhalation

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 pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	5minutes after the patients was sedated
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	5minutes after the patients was sedated
Primary	cardiac output by pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	2 minutes after passive leg raising
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	2 minutes after passive leg raising
Primary	cardiac output by pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	15 minutes after termination of passive leg raising
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	15 minutes after termination of passive leg raising
Primary	cardiac output by pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	30 minutes after dobutamine infusion
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	30 minutes after dobutamine infusion
Primary	cardiac output by pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	30 minutes after termination of dobutamine infusion
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	30 minutes after termination of dobutamine infusion
Primary	cardiac output by pulmonary artery catheter	measuring cardiac output using pulmonary artery catheter	30 minutes after nitric oxide inhalation
Primary	cardiac output by electrical cardiometry	measuring cardiac output using electrical cardiometry	30 minutes after nitric oxide inhalation