- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05815563
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
Conditions
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
-
-
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Cairo, Egypt, 11562
- Faculty of medicine
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-
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.
Sponsor
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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