NCT02340416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

January 13, 2015

Last Update Submit

March 24, 2016

Conditions

Cerebral Microemboli

Keywords

orthopedic surgeriesgeneral anesthesia

Outcome Measures

Primary Outcomes (1)

  • Cerebral microemboli detection

    prior and directly after surgery

Interventions

Transcranial Doppler Ultrasound, DWL Doppler BoxXDEVICE
Also known as: Near Infrared Spectroscopy, Hamamatsu Niro-200Nx

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

orthopedic patients

You may qualify if:

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

You may not qualify if:

  • severe valvular heart defect
  • acute neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 28199523DERIVED

MeSH Terms

Interventions

Ultrasonography, Doppler, TranscranialSpectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

EchoencephalographyNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographyUltrasonographyUltrasonography, DopplerDiagnostic Techniques, NeurologicalInvestigative TechniquesSpectrum AnalysisChemistry Techniques, Analytical

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 16, 2015

Study Start

August 1, 2014

Primary Completion

March 1, 2015

Study Completion

January 1, 2016

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

AU(1)