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Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

Primary Purpose

Pulmonary Arterial Hypertension, Right Ventricular Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
passive leg raising
dobutamine test
inhaled nitric oxide
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongshan hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with pulmonary artery hypertension and/or right ventricular dysfunction

Arm Description

Outcomes

Primary Outcome Measures

cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry
cardiac output by pulmonary artery catheter
measuring cardiac output using pulmonary artery catheter
cardiac output by electrical cardiometry
measuring cardiac output using electrical cardiometry

Secondary Outcome Measures

Full Information

First Posted
September 23, 2022
Last Updated
October 19, 2022
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05587400
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Right Ventricular Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with pulmonary artery hypertension and/or right ventricular dysfunction
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
passive leg raising
Intervention Description
transfer a patient from semi-recumbent position to supine position with a 45° leg lifting
Intervention Type
Drug
Intervention Name(s)
dobutamine test
Intervention Description
infusion dobutamine
Intervention Type
Drug
Intervention Name(s)
inhaled nitric oxide
Intervention Description
nitric oxide inhalation
Primary Outcome Measure Information:
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
5minutes after the patients was sedated
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
5minutes after the patients was sedated
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
2 minutes after passive leg raising
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
2 minutes after passive leg raising
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
15 minutes after termination of passive leg raising
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
15 minutes after termination of passive leg raising
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
30 minutes after dobutamine infusion
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
30 minutes after dobutamine infusion
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
30 minutes after termination of dobutamine infusion
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
30 minutes after termination of dobutamine infusion
Title
cardiac output by pulmonary artery catheter
Description
measuring cardiac output using pulmonary artery catheter
Time Frame
30 minutes after nitric oxide inhalation
Title
cardiac output by electrical cardiometry
Description
measuring cardiac output using electrical cardiometry
Time Frame
30 minutes after nitric oxide inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Luo, PhD
Phone
02164041990
Ext
3659
Email
luo.zhe@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang-wei Hao, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-wei Tu, PhD
Phone
64041990
Ext
2923
Email
tu.guowei@zs-hospital.sh.cn

12. IPD Sharing Statement

Learn more about this trial

Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

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