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:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cerebral microemboli detection
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
Clemens Kietaibl
M.D.
Medical University of Vienna
Study Sites (1)
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