Perioperative Three-dimensional Echocardiography in Cardioanesthesia.

January 11, 2022 updated by: University Hospital Tuebingen
The aim of this study is to investigate the significance of intraoperative echocardiography on the surgical course and association with patient outcome. Of particular interest is the three-dimensional assessment of cardiac and valvular function. The patient course from surgery to the time of hospital discharge will be followed up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Tübingen, Germany
        • Recruiting
        • Universitatsklinikum Tubingen
        • Contact:
          • Harry Magunia, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mixed population of adult patients undergoing cardiac surgery.

Description

Inclusion Criteria:

  • Cardiac surgery or surgery on the vessels near the heart

Exclusion Criteria:

  • Pregnant patients
  • Unfeasibility of intraoperative echocardiography in contraindications to transesophageal echocardiography: esophageal carcinoma, varices, diverticula, strictures, acute esophagitis, previous esophageal or gastric bleeding, symptomatic hiatal hernia.
  • No written consent obtainable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In Hospital Mortality
Time Frame: up to 90 days
up to 90 days
1-year Mortality
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU Length of Stay
Time Frame: up to 90 days
up to 90 days
Days on Mechanical Ventilation
Time Frame: up to 90 days
up to 90 days
Days with Circulatory Support
Time Frame: up to 45 days
up to 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 13, 2022

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 11, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EchoRegistryCardiac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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