Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05587400
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Zhongshan Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Guang-wei Hao, PhD
Principal Investigator Affiliation Fudan University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension, Right Ventricular Dysfunction
Arms & Interventions

Arms

Experimental: patients with pulmonary artery hypertension and/or right ventricular dysfunction

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zhongshan hospital Fudan University, Shanghai, Shanghai, China

Status

Recruiting

Address

Zhongshan hospital Fudan University

Shanghai, Shanghai, 200032

Site Contact

Guo-wei Tu, PhD

tu.guowei@zs-hospital.sh.cn

64041990 #2923

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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