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

NCT ID: NCT02340416

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Microemboli

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcranial Doppler Ultrasound, DWL Doppler BoxX

Intervention Type DEVICE

Other Intervention Names

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Near Infrared Spectroscopy, Hamamatsu Niro-200Nx

Eligibility Criteria

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Inclusion Criteria

* hip prosthesis
* knee prosthesis
* shoulder prosthesis
* spine surgery

Exclusion Criteria

* severe valvular heart defect
* acute neurological disorder
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Clemens Kietaibl

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Vienna, Vienna, Austria

Site Status

Countries

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Austria

References

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Kietaibl C, Engel A, Horvat Menih I, Huepfl M, Erdoes G, Kubista B, Ullrich R, Windhager R, Markstaller K, Klein KU. Detection and differentiation of cerebral microemboli in patients undergoing major orthopaedic surgery using transcranial Doppler ultrasound. Br J Anaesth. 2017 Mar 1;118(3):400-406. doi: 10.1093/bja/aex001.

Reference Type DERIVED
PMID: 28199523 (View on PubMed)

Other Identifiers

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1633/2013

Identifier Type: -

Identifier Source: org_study_id

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