Paceport Swan-Ganz Data Collection Study

NCT ID: NCT06812975

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-18

Study Completion Date

2025-07-08

Brief Summary

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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

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Conditions

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RV Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group

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

No intervention

Intervention Type OTHER

This is an observational study

Interventions

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No intervention

This is an observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tjorvi E Perry

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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ANES-2020-29144

Identifier Type: -

Identifier Source: org_study_id

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