NCT05191173

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 13, 2022

Status Verified

September 1, 2021

Enrollment Period

5.5 years

First QC Date

September 23, 2021

Last Update Submit

January 11, 2022

Conditions

Cardiac DiseaseVascular Diseases

Outcome Measures

Primary Outcomes (2)

  • In Hospital Mortality

    up to 90 days

  • 1-year Mortality

    1 year

Secondary Outcomes (3)

  • ICU Length of Stay

    up to 90 days

  • Days on Mechanical Ventilation

    up to 90 days

  • Days with Circulatory Support

    up to 45 days

Interventions

Cardiac SurgeryPROCEDURE

No intervention, just observation is performed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mixed population of adult patients undergoing cardiac surgery.

You may qualify if:

  • Cardiac surgery or surgery on the vessels near the heart

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Tübingen

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

Heart DiseasesVascular Diseases

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Central Study Contacts

Harry Magunia, MD, PhD

CONTACT

+4970712986564harry.magunia@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

January 13, 2022

Study Start

June 1, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 13, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)