Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics

August 28, 2023 updated by: mohamed abdelghany ali, Cairo University

Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block for Upper Extremity Procedures in Children.

Few data are available for the PI as a tool for evaluation of peripheral block success in pediatric patients. Furthermore, there is currently no cut-off value defined for the accuracy of the PI in the detection of successful block.

Study Overview

Status

Not yet recruiting

Detailed Description

modify plan for intraoperative and postoperative analgesia. Perfusion index is an assessment of the pulsatile strength at a monitoring site; it is calculated by means of pulse oximetry by expressing the pulsatile signal as a percentage of the non pulsatile signal by a specialized probe, both of which are derived from the amount of infrared light absorbed.PI can provide useful information about the peripheral perfusion status of the patients and works as an index for sympathetic stimulation. Recent study suggested that PI could be used as an early and sensitive indicator to assess the development of sympathectomy induced by brachial plexus block in conscious adults; it is more sensitive than other parameters such as changes of skin temperature gradients or mean arterial pressure (MAP)

Study Type

Observational

Enrollment (Estimated)

59

Contacts and Locations

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

Study Locations

      • Cairo, Egypt, 11562
        • Faculty of medicine

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

59 pediatric patients scheduled for elective upper extremity procedures will receive general anesthesia and trained anesthesiologist will perform ultrasound guided supraclavicular brachial plexus block on the ipsilateral side of the procedure.

Description

Inclusion Criteria:

Age group: (3-14) years old. ASA class I-II

Exclusion Criteria:

  • Patients with age below 3 year or older than 14 years. Parent refusal. Patients with apparent infection at site of needle insertion. Patients with any coagulation disorder. Patients with known neuropathy or brachial plexus injury. Patients with any cardiac, hepatic, renal or neurological disease

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: Intraoperative
The sensitivity of perfusion index in predicting success of supraclavicular brachial plexus block in pediatric patients.
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temperature
Time Frame: Intraoperative
The sensitivity of temperature change in predicting success of supraclavicular brachial plexus block in pediatric patients.
Intraoperative

Collaborators and Investigators

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

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 (Estimated)

September 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MD2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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