Tissue Oxygen Index and Pulsatility Index in Orthopedic S... | NCT02340416

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

NCT02340416

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Mar 25, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Cerebral Microemboli

Interventions

Transcranial Doppler Ultrasound, DWL Doppler BoxX

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Mar 2015Actual

Completion Date

Jan 2016Actual

First Submitted Date

Jan 13, 2015

First Submission Date that Met QC Criteria

Jan 15, 2015

First Posted Date

Jan 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Doppler Ultrasound, DWL Doppler BoxX	Device			Near Infrared Spectroscopy, Hamamatsu Niro-200Nx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral microemboli detection		prior and directly after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hip prosthesis
knee prosthesis
shoulder prosthesis
spine surgery

Exclusion Criteria:

severe valvular heart defect
acute neurological disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

orthopedic patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28199523	Derived	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.

ID	Term
D017585	Ultrasonography, Doppler, Transcranial
D019265	Spectroscopy, Near-Infrared

ID	Term
D004453	Echoencephalography
D009485	Neuroradiography
D059906	Neuroimaging
D003952	Diagnostic Imaging