Paceport Swan-Ganz Data Collection Study

NCT06812975 | Completed

• 1 other identifier: ANES-2020-29144
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

RV Dysfunction

Outcome Measures

Primary Outcomes (1)

• Arterial waveform

  The slope of the diastolic right ventricular waveform which includes measures of RV end-diastolic pressure and RV contractility (dPdt)

  24 hours postoperative

Study Arms (1)

Study group

undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation

Other: No intervention

Interventions

No intervention OTHER

This is an observational study

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation

You may qualify if:

• Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
• Participate in the Informed Consent process and sign/date the approved informed consent forms
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Study Officials

• Tjorvi E Perry

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: September 18, 2021
• Primary Completion: July 8, 2025
• Study Completion: July 8, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)