Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Not Applicable

Recruiting

• Conditions: Right Ventricular Dysfunction; Pulmonary Arterial Hypertension
• Interventions: Behavioral: passive leg raising; Drug: dobutamine test; Drug: inhaled nitric oxide

• Registration Number: NCT05587400
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-27
• Study First Submitted: 2022-09-23
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-19
• Last Update Submitted: 2022-10-19
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 199

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with pulmonary artery hypertension and/or right ventricular dysfunction	inhaled nitric oxide	-
patients with pulmonary artery hypertension and/or right ventricular dysfunction	passive leg raising	-
patients with pulmonary artery hypertension and/or right ventricular dysfunction	dobutamine test	-

Primary Outcome Measures

Name	Time	Method
cardiac output by pulmonary artery catheter	30 minutes after nitric oxide inhalation	measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry	30 minutes after nitric oxide inhalation	measuring cardiac output using electrical cardiometry

Trial Locations

Locations (1)

Zhongshan hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China