Perfusion IndexNCT02989896
Perfusion Index in the Success of Peripheral Nerve Block
An observational study of Perfusion Index and Peripheral Nerve Block Success, run by Erzincan University.
Trial summary
After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Perfusion Index, Peripheral Nerve Block Success
- What is being tested?
- perfusion index
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Sep 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elective orthopedic lower extremity surgery patients
Who may be able to join
- Over 65 years old
- ASA I-III
Who cannot join
- Patients under 65 years old
- Patients contraindicated in regional anesthesia
- Patients with local anesthetic allergy
- Patients with injection site infection
- Patients who do not accept the procedure
About this study
Official title: Evaluation of Perfusion Index in the Success of Peripheral Nerve Block in Advanced Age Patients
After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity.
- Conditions
- Perfusion Index, Peripheral Nerve Block Success
- Being tested
- perfusion index
- Keywords
- Perfusion index, Peripheral nerve block success, older age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion indexDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
patient's perfusion index
Measured: nine month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perfusion IndexStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989896
- Sponsor's protocol ID
- ERZINCAN UNIVERSITY 5
- Status last verified
- Dec 2016
- First submitted
- 4 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.
PubMed 11149448Pearson AC, Gudipati CV, Labovitz AJ. Effects of aging on left ventricular structure and function. Am Heart J. 1991 Mar;121(3 Pt 1):871-5. doi: 10.1016/0002-8703(91)90201-r.
PubMed 1825740Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
PubMed 12072670Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.
PubMed 23397432Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.
PubMed 16790660Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
PubMed 23055034Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
PubMed 12580205
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perfusion Index in the Success of Peripheral Nerve Block in Advanced Age Patients
- ClinicalTrials.gov ID
- NCT02989896
- Acronym / sponsor ID
- ERZINCAN UNIVERSITY 5
- Conditions
- Perfusion Index, Peripheral Nerve Block Success
- Keywords
- Perfusion index, Peripheral nerve block success, older age
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Dec 2016 (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.
After a successful peripheral nerve block, blockade of sympathetic nerve fibers results in local vasodilatation, increased local blood flow, and increased skin temperature.Increased permeability index; Can be used as a reliable tool for evaluating block activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elective orthopedic lower extremity surgery patients
Key inclusion criteria (2 listed)
- Over 65 years old
- ASA I-III
Key exclusion criteria (5 listed)
- Patients under 65 years old
- Patients contraindicated in regional anesthesia
- Patients with local anesthetic allergy
- Patients with injection site infection
- Patients who do not accept the procedure
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 |
|---|---|---|
| perfusion index | Device | – |
Primary outcome
patient's perfusion index
Time frame: nine month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Background: PubMed 11149448Curatolo M, Petersen-Felix S, Arendt-Nielsen L. Sensory assessment of regional analgesia in humans: a review of methods and applications. Anesthesiology. 2000 Dec;93(6):1517-30. doi: 10.1097/00000542-200012000-00025. No abstract available.
- Background: PubMed 1825740Pearson AC, Gudipati CV, Labovitz AJ. Effects of aging on left ventricular structure and function. Am Heart J. 1991 Mar;121(3 Pt 1):871-5. doi: 10.1016/0002-8703(91)90201-r.
- Background: PubMed 12072670Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med. 2002 Jun;30(6):1210-3. doi: 10.1097/00003246-200206000-00006.
- Background: PubMed 23397432Kus A, Gurkan Y, Gormus SK, Solak M, Toker K. Usefulness of perfusion index to detect the effect of brachial plexus block. J Clin Monit Comput. 2013 Jun;27(3):325-8. doi: 10.1007/s10877-013-9439-4. Epub 2013 Feb 10.
- Background: PubMed 16790660Galvin EM, Niehof S, Verbrugge SJ, Maissan I, Jahn A, Klein J, van Bommel J. Peripheral flow index is a reliable and early indicator of regional block success. Anesth Analg. 2006 Jul;103(1):239-43, table of contents. doi: 10.1213/01.ane.0000220947.02689.9f.
- Background: PubMed 23055034Sebastiani A, Philippi L, Boehme S, Closhen D, Schmidtmann I, Scherhag A, Markstaller K, Engelhard K, Pestel G. Perfusion index and plethysmographic variability index in patients with interscalene nerve catheters. Can J Anaesth. 2012 Dec;59(12):1095-101. doi: 10.1007/s12630-012-9796-3. Epub 2012 Oct 2.
- Background: PubMed 12580205Goldman JM, Petterson MT, Kopotic RJ, Barker SJ. Masimo signal extraction pulse oximetry. J Clin Monit Comput. 2000;16(7):475-83. doi: 10.1023/a:1011493521730.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perfusion Index and Peripheral Nerve Block Success, run by Erzincan University.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
patient's perfusion index (time frame: nine month). 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 NCT02989896, which also lists 7 linked publications.
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 12 Dec 2016.