Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

NCT ID: NCT05587400

Last Updated: 2022-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-27

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension Right Ventricular Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients with pulmonary artery hypertension and/or right ventricular dysfunction

Group Type EXPERIMENTAL

passive leg raising

Intervention Type BEHAVIORAL

transfer a patient from semi-recumbent position to supine position with a 45° leg lifting

dobutamine test

Intervention Type DRUG

infusion dobutamine

inhaled nitric oxide

Intervention Type DRUG

nitric oxide inhalation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

passive leg raising

transfer a patient from semi-recumbent position to supine position with a 45° leg lifting

Intervention Type BEHAVIORAL

dobutamine test

infusion dobutamine

Intervention Type DRUG

inhaled nitric oxide

nitric oxide inhalation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guang-wei Hao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhe Luo, PhD

Role: CONTACT

02164041990 ext. 3659

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guo-wei Tu, PhD

Role: primary

64041990 ext. 2923

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COMEEC

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.