CompletedNot Applicable

Paceport Swan-Ganz Data Collection Study

United States152 participantsStarted 2021-09-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Arterial waveform

Timeframe: 24 hours postoperative

Trial details

NCT IDNCT06812975

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-08

View on ClinicalTrials.gov More RV Dysfunction trials