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NCT02655094 Clinical Trial

Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery

Pulmonary Edema Clinical Trial

Official title:
Unilateral Pulmonary Edema After Minimal-invasive Mitral Valve Surgery: a Retrospective Single Center Observation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02655094
Other study ID # IN-MIC-01
Secondary ID
Status Completed
Phase N/A
First received December 5, 2015
Last updated June 3, 2017
Start date February 2016
Est. completion date October 2016

Study information
Verified date June 2017
Source University of Schleswig-Holstein
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. This is a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure.

Description:

Unilateral pulmonary edema after minimal-invasive mitral valve surgery is a rare but in some cases severe complications, sometimes causing extracorporeal life support. The investigators have observed over several years 5 cases of instantaneous postoperative severe pulmonary edema. After having studied the available literature on this particular topic the investigators have decided to prepare a retrospective analysis of over 200 minimal-invasive mitral valve surgery procedure focusing on radiological and clinical signs of unilateral pulmonary edema.

Recruitment information / eligibility
Status Completed
Enrollment 256
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- >= 18 years of age

Exclusion Criteria:

- urgent surgery

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany universitätsklinikum Schleswig-Holstein Kiel Schleswig-Holstein

Sponsors (1)
Lead Sponsor Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Unilateral right sided pulmonary edema or congestion after surgery retrospective analysis using the electronic and the paper-based patient specific database Postoperatively within the first 12h after admission to intensive care unit
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