NCT02820727

Brief Summary

This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

July 16, 2018

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

June 6, 2016

Last Update Submit

July 13, 2018

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

  • Time on Intensive Care Unit (ICU)

    Duration of ICU stay

    up to 60 days

Secondary Outcomes (5)

  • Time to hospital discharge

    up to 120 days

  • Catecholamine dosages

    up to 24 hours

  • Catecholamine free days

    up to 60 days

  • Hours on mechanical ventilation

    up to 1440 hours

  • Organ failure during ICU stay

    up to 60 days

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult cardiac surgical patients

You may qualify if:

  • informed consent given
  • cardiac surgical procedure
  • left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation

You may not qualify if:

  • pregnant patients
  • contraindication for transesophageal echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tubingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

  • Magunia H, Jordanow A, Keller M, Rosenberger P, Nowak-Machen M. The effects of anesthesia induction and positive pressure ventilation on right-ventricular function: an echocardiography-based prospective observational study. BMC Anesthesiol. 2019 Nov 4;19(1):199. doi: 10.1186/s12871-019-0870-z.

    PMID: 31684877DERIVED

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Harry Magunia, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

July 1, 2016

Study Start

October 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

July 16, 2018

Record last verified: 2016-06

Locations

DE(1)