The Role of Perfusion Index in Children

November 30, 2020 updated by: İLKE KÜPELİ, Erzincan University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • will undergo elective upper limb surgery,
  • 2- 10 years old,
  • ASA I

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Collaborators

Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

January 26, 2020

First Posted (Actual)

January 29, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 30, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • EBYU PNB CHILDREN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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