PediatricsNCT05815563
Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block in Pediatrics
An observational study of Pediatrics and Anesthesia, Local, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Pediatrics, Anesthesia, Local
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Age group: (3-14) years old. ASA class I-II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Conditions
- Pediatrics, Anesthesia, Local
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion index
The sensitivity of perfusion index in predicting success of supraclavicular brachial plexus block in pediatric patients.
Measured: Intraoperative
Secondary outcomes (1)
Temperature
The sensitivity of temperature change in predicting success of supraclavicular brachial plexus block in pediatric patients.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startSep 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed abdelghany ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815563
- Sponsor's protocol ID
- MD2021
- Status last verified
- Aug 2023
- First submitted
- 4 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Peripheral Perfusion Index in Predicting Successful Supraclavicular Brachial Plexus Block for Upper Extremity Procedures in Children.
- ClinicalTrials.gov ID
- NCT05815563
- Acronym / sponsor ID
- MD2021
- Conditions
- Pediatrics, Anesthesia, Local
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Age group: (3-14) years old. ASA class I-II
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perfusion index
Time frame: Intraoperative
The sensitivity of perfusion index in predicting success of supraclavicular brachial plexus block in pediatric patients.
1 secondary outcome
Temperature
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatrics and Anesthesia, Local, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion index (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.