NCT04245735

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

January 26, 2020

Last Update Submit

November 30, 2020

Conditions

Perfusion Index

Outcome Measures

Primary Outcomes (1)

  • perfusion index

    To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.

    6 months

Interventions

perfusion indexDIAGNOSTIC_TEST

To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • will undergo elective upper limb surgery,
  • years old,
  • ASA I

You may not qualify if:

  • have regional anesthesia contraindications,
  • allergic to local anesthetics,
  • having an infection at the injection site
  • patients who do not accept the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 28854539RESULT

  • Kus 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.

    PMID: 23397432RESULT

  • Galvin 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.

    PMID: 16790660RESULT

  • Sebastiani 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.

    PMID: 23055034RESULT

  • Xu 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.

    PMID: 24174910RESULT

MeSH Terms

Interventions

Perfusion Index

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

ILKE KUPELI, MD

CONTACT

05555485632ilkeser2004@gmail.com

ILKE KUPELI

CONTACT

05555485632ilkeser2004@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof.

Study Record Dates

First Submitted

January 26, 2020

First Posted

January 29, 2020

Study Start

December 1, 2020

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share