Perfusion IndexNCT04245735
The Role of Perfusion Index in Children
An observational study of Perfusion Index, run by Erzincan University.
Trial summary
The purpose of our study is to test the usability of the perfusion index in evaluating the success of the peripheral nerve block applied under sedation in children. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Perfusion Index
- What is being tested?
- perfusion index
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Sep 2021
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 60 patients with ASA 1 between the ages 2-10 who will undergo elective upper extremity surgery will be included in the study.
Who may be able to join
- will undergo elective upper limb surgery,
- 2- 10 years old,
- ASA I
Who cannot join
- have regional anesthesia contraindications,
- allergic to local anesthetics,
- having an infection at the injection site
- patients who do not accept the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Peripheral Perfusion Index in Evaluating the Success of Peripheral Nerve Block in Children Under Sedation
The purpose of our study is to test the usability of the perfusion index in evaluating the success of the peripheral nerve block applied under sedation in children.
- Conditions
- Perfusion Index
- Being tested
- perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion indexDiagnostic test
To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Collaborators
- Derince Training and Research Hospital
- Responsible party
- Principal investigator, İLKE KÜPELİ, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245735
- Sponsor's protocol ID
- EBYU PNB CHILDREN
- Status last verified
- Nov 2020
- First submitted
- 26 Jan 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
PubMed 28854539Kus 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 23055034Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.
PubMed 24174910
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Peripheral Perfusion Index in Evaluating the Success of Peripheral Nerve Block in Children Under Sedation
- ClinicalTrials.gov ID
- NCT04245735
- Acronym / sponsor ID
- EBYU PNB CHILDREN
- Conditions
- Perfusion Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Collaborators
- Derince Training and Research Hospital
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 29 Jan 2020 (actual)
- 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.
The purpose of our study is to test the usability of the perfusion index in evaluating the success of the peripheral nerve block applied under sedation in children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 60 patients with ASA 1 between the ages 2-10 who will undergo elective upper extremity surgery will be included in the study.
Key inclusion criteria (3 listed)
- will undergo elective upper limb surgery,
- 2- 10 years old,
- ASA I
Key exclusion criteria (4 listed)
- have regional anesthesia contraindications,
- allergic to local anesthetics,
- having an infection at the injection site
- 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 indexTo test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation. | Diagnostic test | – |
Primary outcome
perfusion index
Time frame: 6 months
To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Results publication: PubMed 28854539Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 24174910Xu Z, Zhang J, Shen H, Zheng J. Assessment of pulse oximeter perfusion index in pediatric caudal block under basal ketamine anesthesia. ScientificWorldJournal. 2013 Sep 19;2013:183493. doi: 10.1155/2013/183493. eCollection 2013.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Perfusion Index, 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 3 inclusion and 4 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 1 Dec 2020. 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?
Contact ILKE KUPELI, MD (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perfusion index (time frame: 6 months). 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 NCT04245735, which also lists 5 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 1 Dec 2020.