Cerebral MicroemboliNCT02340416
Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
An observational study of Cerebral Microemboli, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cerebral Microemboli
- What is being tested?
- Transcranial Doppler Ultrasound, DWL Doppler BoxX
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: orthopedic patients
Who may be able to join
- hip prosthesis
- knee prosthesis
- shoulder prosthesis
- spine surgery
Who cannot join
- severe valvular heart defect
- acute neurological disorder
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dept. of Anaesthesiology & Intensive Care, Vienna General Hospital, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
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.
- Conditions
- Cerebral Microemboli
- Being tested
- Transcranial Doppler Ultrasound, DWL Doppler BoxX
- Keywords
- orthopedic surgeries, general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler Ultrasound, DWL Doppler BoxXDevice
Also called Near Infrared Spectroscopy, Hamamatsu Niro-200Nx
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral microemboli detection
Measured: prior and directly after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral MicroemboliStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Kietaibl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340416
- Sponsor's protocol ID
- 1633/2013
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2015
- Last updated
- 25 Mar 2016
- Results posted
- No
Publications
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.
PubMed 28199523
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial
- ClinicalTrials.gov ID
- NCT02340416
- Acronym / sponsor ID
- 1633/2013
- Conditions
- Cerebral Microemboli
- Keywords
- orthopedic surgeries, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- orthopedic patients
Key inclusion criteria (4 listed)
- hip prosthesis
- knee prosthesis
- shoulder prosthesis
- spine surgery
Key exclusion criteria (2 listed)
- severe valvular heart defect
- acute neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Doppler Ultrasound, DWL Doppler BoxXAlso: Near Infrared Spectroscopy, Hamamatsu Niro-200Nx | Device | – |
Primary outcome
Cerebral microemboli detection
Time frame: prior and directly after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Derived from this study: PubMed 28199523Kietaibl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Microemboli, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral microemboli detection (time frame: prior and directly after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02340416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.