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

Cerebral Microemboli Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340416
• Other study ID #: 1633/2013
• Status: Completed
• Phase: N/A
• First received: January 13, 2015
• Last updated: March 24, 2016
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• hip prosthesis

• knee prosthesis

• shoulder prosthesis

• spine surgery

Exclusion Criteria:

• severe valvular heart defect

• acute neurological disorder

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Microemboli

Intervention

Device:
• Transcranial Doppler Ultrasound, DWL Doppler BoxX

Locations

Country	Name	City	State
Austria	Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral microemboli detection		prior and directly after surgery	No