Paceport Swan-Ganz Data Collection Study

Active, not recruiting

• Conditions: RV Dysfunction

• Registration Number: NCT06812975
• Lead Sponsor: University of Minnesota

Brief Summary

In association with Edwards LifeSciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of RV dysfunction in cardiothoracic and liver surgery patients at UMMC. This is a prospective, non-interventional, observational study.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-18
• Study First Submitted: 2025-02-02
• Study First Submitted QC: 2025-02-02
• Study First Posted: 2025-02-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
2. Participate in the Informed Consent process and sign/date the approved informed consent forms
3. Projected to receive Swan-Ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

Exclusion Criteria

1. Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
2. Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
3. Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
4. Patients unable to consent to participating in the study
5. Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery
6. Patients under the age of 18 years old
7. Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
8. Patients allergic to FORE-SIGHT Elite sensor adhesive
9. Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial waveform	24 hours postoperative	The slope of the diastolic right ventricular waveform which includes measures of RV end-diastolic pressure and RV contractility (dPdt)

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States