Clinical trial NCT05587400: Consistency of Electrical Cardiometry and Pulmonary Artery Catheter
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Right Ventricular Dysfunction
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: cardiac output by pulmonary artery catheter
timeFrame: 5minutes after the patients was sedated
measure: cardiac output by electrical cardiometry
timeFrame: 5minutes after the patients was sedated
measure: cardiac output by pulmonary artery catheter
timeFrame: 2 minutes after passive leg raising
measure: cardiac output by electrical cardiometry
timeFrame: 2 minutes after passive leg raising
measure: cardiac output by pulmonary artery catheter
timeFrame: 15 minutes after termination of passive leg raising
measure: cardiac output by electrical cardiometry
timeFrame: 15 minutes after termination of passive leg raising
measure: cardiac output by pulmonary artery catheter
timeFrame: 30 minutes after dobutamine infusion
measure: cardiac output by electrical cardiometry
timeFrame: 30 minutes after dobutamine infusion
measure: cardiac output by pulmonary artery catheter
timeFrame: 30 minutes after termination of dobutamine infusion
measure: cardiac output by electrical cardiometry
timeFrame: 30 minutes after termination of dobutamine infusion
measure: cardiac output by pulmonary artery catheter
timeFrame: 30 minutes after nitric oxide inhalation
measure: cardiac output by electrical cardiometry
timeFrame: 30 minutes after nitric oxide inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guang-wei Hao, PhD
role: PRINCIPAL_INVESTIGATOR
References: