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Clinical Trials/NCT02340416
NCT02340416CompletedNot Applicable

Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial

Medical University of Vienna1 site in 1 country50 target enrollmentStarted: August 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Cerebral microemboli detection
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •hip prosthesis
  • •knee prosthesis
  • •shoulder prosthesis
  • •spine surgery

Exclusion Criteria

  • •severe valvular heart defect
  • •acute neurological disorder

Outcomes

Primary Outcomes

Cerebral microemboli detection

Time Frame: prior and directly after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Clemens Kietaibl

M.D.

Medical University of Vienna

Study Sites (1)

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