Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients

September 1, 2023 updated by: aijun xu, Tongji Hospital

Evaluation of Perfusion Index as an Objective Measure for Supraclavicular Brachial Plexus Block in Pediatric Patients

The aim of the present study is to evaluate the effects of supraclavicular brachial plexus block using perfusion index in pediatric patients undergoing Upper limb surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The role of perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients. The aim of the present study is to assess the effects of perfusion index on success of supraclavicular brachial plexus block in pediatric patients.

Study Type

Observational

Enrollment (Actual)

104

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital

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

1 month to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

ASA physical status I-II,Age 1 month-12 year,Children undergoing Upper limb surgery.

Description

Inclusion Criteria:

  • ASA physical status I-II
  • Children undergoing Upper limb surgery.
  • Parents' agreement.

Exclusion Criteria:

  • Parents' refusal.
  • Children with behavioral changes
  • Children with physical developmental delay
  • Children on treatment with sedative or anticonvulsant.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sevoflurane Group
sevoflurane is used for anesthetic induction
Device: perfusion index
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
Propofol Group
intravenous anesthetic propofol is used for anesthetic induction
Device: perfusion index
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perfusion index
Time Frame: the time span between 1 day preoperative and 24 hours after surgery
Correlation between success of supraclavicular brachial plexus block and perfusion index
the time span between 1 day preoperative and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean arterial blood pressure
Time Frame: the time span between 1 day preoperative and 24 hours after surgery
perioperative mean arterial blood pressure in mmHg
the time span between 1 day preoperative and 24 hours after surgery
heart rate
Time Frame: the time span between 1 day preoperative and 24 hours after surgery
perioperative heart rate as beat/min
the time span between 1 day preoperative and 24 hours after surgery
PI ratio
Time Frame: up to 10 minutes
Correlate between baseline PI and 10min after supraclavicular brachial plexus block
up to 10 minutes

Collaborators and Investigators

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

Sponsor

Tongji Hospital

Investigators

  • Study Chair: Hong Liu, Dr., Huazhong university, Tongji medical college

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 (Actual)

July 6, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 28, 2019

First Submitted That Met QC Criteria

January 2, 2020

First Posted (Actual)

January 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PISP

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

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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