Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05815563
Collaborator
(none)
59
Enrollment
1
Location
6
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    59 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block for Upper Extremity Procedures in Children.
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Nov 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Perfusion index [Intraoperative]

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

    Secondary Outcome Measures

    1. Temperature [Intraoperative]

      The sensitivity of temperature change in predicting success of supraclavicular brachial plexus block in pediatric patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 14 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo Egypt 11562

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    mohamed abdelghany ali, Lecturer of anesthesia, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05815563
    Other Study ID Numbers:
    • MD2021
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 18, 2023