Consistency of Electrical Cardiometry and Pulmonary Artery Catheter

• Sponsor: Shanghai Zhongshan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05587400
• Collaborator: (none)
• Enrollment: 199
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.2
• Patients Per Site Per Month: 6.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension; Right Ventricular Dysfunction	Behavioral: passive leg raising; Drug: dobutamine test; Drug: inhaled nitric oxide	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 199 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Jul 27, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. cardiac output by pulmonary artery catheter [5minutes after the patients was sedated]

   measuring cardiac output using pulmonary artery catheter

2. cardiac output by electrical cardiometry [5minutes after the patients was sedated]

   measuring cardiac output using electrical cardiometry

3. cardiac output by pulmonary artery catheter [2 minutes after passive leg raising]

   measuring cardiac output using pulmonary artery catheter

4. cardiac output by electrical cardiometry [2 minutes after passive leg raising]

   measuring cardiac output using electrical cardiometry

5. cardiac output by pulmonary artery catheter [15 minutes after termination of passive leg raising]

   measuring cardiac output using pulmonary artery catheter

6. cardiac output by electrical cardiometry [15 minutes after termination of passive leg raising]

   measuring cardiac output using electrical cardiometry

7. cardiac output by pulmonary artery catheter [30 minutes after dobutamine infusion]

   measuring cardiac output using pulmonary artery catheter

8. cardiac output by electrical cardiometry [30 minutes after dobutamine infusion]

   measuring cardiac output using electrical cardiometry

9. cardiac output by pulmonary artery catheter [30 minutes after termination of dobutamine infusion]

   measuring cardiac output using pulmonary artery catheter

10. cardiac output by electrical cardiometry [30 minutes after termination of dobutamine infusion]

    measuring cardiac output using electrical cardiometry

11. cardiac output by pulmonary artery catheter [30 minutes after nitric oxide inhalation]

    measuring cardiac output using pulmonary artery catheter

12. cardiac output by electrical cardiometry [30 minutes after nitric oxide inhalation]

    measuring cardiac output using electrical cardiometry

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan hospital Fudan University	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

• Shanghai Zhongshan Hospital

Investigators

• Principal Investigator: Guang-wei Hao, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Zhongshan Hospital
• ClinicalTrials.gov Identifier: NCT05587400
• Other Study ID Numbers: COMEEC
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Ventricular Dysfunction; Ventricular Dysfunction, Right; Dobutamine; Nitric Oxide

Study Results

No Results Posted as of Oct 20, 2022