Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Arterial Hypertension; Right Ventricular Dysfunction
• Intervention / Treatment: Behavioral: passive leg raising; Drug: dobutamine test; Drug: inhaled nitric oxide

• Study Type: Interventional
• Enrollment (Anticipated): 199
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhe Luo, PhD; Phone Number: 3659 02164041990; Email: luo.zhe@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Contact: Guo-wei Tu, PhD; Phone Number: 2923 64041990; Email: tu.guowei@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Guang-wei Hao, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 27, 2022
• Primary Completion (ANTICIPATED): December 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (ACTUAL): October 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Right; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Nitric Oxide; Dobutamine
• Other Study ID Numbers: COMEEC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No