Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Arterial Hypertension, Right Ventricular Dysfunction

Intervention / Treatment
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* Behavioral: passive leg raising
* Drug: dobutamine test
* Drug: inhaled nitric oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with pulmonary artery hypertension and/or right ventricular dysfunction<br> | Behavioral: passive leg raising<br>* transfer a patient from semi-recumbent position to supine position with a 45° leg lifting<br>Drug: dobutamine test<br>* infusion dobutamine<br>Drug: inhaled nitric oxide<br>* nitric oxide inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 5minutes after the patients was sedated | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 5minutes after the patients was sedated | 
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 2 minutes after passive leg raising | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 2 minutes after passive leg raising | 
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 15 minutes after termination of passive leg raising | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 15 minutes after termination of passive leg raising | 
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 30 minutes after dobutamine infusion | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 30 minutes after dobutamine infusion | 
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 30 minutes after termination of dobutamine infusion | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 30 minutes after termination of dobutamine infusion | 
| cardiac output by pulmonary artery catheter | measuring cardiac output using pulmonary artery catheter | 30 minutes after nitric oxide inhalation | 
| cardiac output by electrical cardiometry | measuring cardiac output using electrical cardiometry | 30 minutes after nitric oxide inhalation |