Paceport Swan-Ganz Data Collection Study

University of Minnesota (UMN)

Status: Active, not recruiting

Conditions: RV Dysfunction

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT06812975

ANES-2020-29144

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Study group

Description:

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

Treatment:

Other: No intervention

Sponsor of this trial

Lead Sponsor

University of Minnesota (UMN)