Completed

NCT Number: NCT02340416

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

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.

Completed

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Key information

Conditions

Cerebral Microemboli

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

hip prosthesis
knee prosthesis
shoulder prosthesis
spine surgery

Exclusion criteria

severe valvular heart defect
acute neurological disorder

Treatment and study plan

Transcranial Doppler Ultrasound, DWL Doppler BoxX

Device

Other names: Near Infrared Spectroscopy, Hamamatsu Niro-200Nx

Primary outcomes

Cerebral microemboli detection

Time frame: prior and directly after surgery

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Jan 16, 2015
Registry last updated: Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.