- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02340416
Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
March 24, 2016 updated by: Clemens Kietaibl, Medical University of Vienna
Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery.
The primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME, detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs) before and after orthopaedic surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, 1090
- Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna
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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
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
orthopedic patients
Description
Inclusion Criteria:
- hip prosthesis
- knee prosthesis
- shoulder prosthesis
- spine surgery
Exclusion Criteria:
- severe valvular heart defect
- acute neurological disorder
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 |
---|---|
Cerebral microemboli detection
Time Frame: prior and directly after surgery
|
prior and directly after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 13, 2015
First Submitted That Met QC Criteria
January 15, 2015
First Posted (Estimate)
January 16, 2015
Study Record Updates
Last Update Posted (Estimate)
March 25, 2016
Last Update Submitted That Met QC Criteria
March 24, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1633/2013
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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