End Diastolic VelocityNCT07197281
Perfusion Index and End Diastolic Velocity Ratios as Predictors of Supraclavicular Block Success in Vascular Access Surgery
An observational study of End Diastolic Velocity and Perfusion Index, run by Assiut University.
Trial summary
This is a prospective observational study investigating the correlation between Perfusion Index (PI) ratio and End Diastolic Velocity (EDV) ratio as early predictors of successful supraclavicular brachial plexus block (SCBPB) in patients undergoing superficialization surgery of the upper limb. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End Diastolic Velocity, Perfusion Index
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are adult patients aged 18-65 years, both male and female, classified as ASA II-VI, and scheduled for elective superficialization procedures (mainly AV fistula superficialization). Patients must be capable of understanding and signing informed consent. Excluded are patients with contraindications to nerve block such as coagulopathy, local infection, allergy to local anesthetics, severe vascular disease, morbid obesity (BMI >35), severe neurological or psychiatric impairment, or those taking vasopressors or beta-blockers that could alter vascular reactivity.
Who may be able to join
- Adults aged 18-65 years
- Both genders
- ASA II-VI classification
- Undergoing elective upper limb superficialization surgery (e.g., AVF superficialization)
- Provided written informed consent
Who cannot join
- Patient refusal
- Coagulopathy or bleeding disorders
- Local infection at injection site
- Allergy to local anesthetics
- Use of vasopressors or beta-blockers
- Severe peripheral vascular disease
- Morbid obesity (BMI > 35)
- Severe neurological or psychiatric disorders
About this study
Official title: Correlation Between Perfusion Index Ratio and End Diastolic Velocity Ratio After Supraclavicular Brachial Plexus Block as an Early Predictor of Successful Block in Superficialization Surgery of the Upper Limb
This is a prospective observational study investigating the correlation between Perfusion Index (PI) ratio and End Diastolic Velocity (EDV) ratio as early predictors of successful supraclavicular brachial plexus block (SCBPB) in patients undergoing superficialization surgery of the upper limb.
Read the detailed description
Regional anesthesia is fundamental for upper limb surgeries, with SCBPB providing dense anesthesia. However, early confirmation of successful block performance remains challenging. Traditional clinical methods (sensory/motor testing) are subjective and delayed. This study proposes using objective, noninvasive indices - PI (evaluated via pulse oximetry) and EDV (measured by Doppler ultrasound) - to determine their accuracy in detecting sympathetic blockade shortly after SCBPB. Early and reliable detection of block success is particularly important in superficialization surgeries such as arteriovenous fistula (AVF) superficialization in patients with compromised vascular status. The results are expected to enhance anesthesia practice by providing quantitative, reproducible, and rapid assessment tools.
- Conditions
- End Diastolic Velocity, Perfusion Index
- Keywords
- End Diastolic Velocity, brachial plexus block, Perfusion Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients scheduled for elective superficialization surgery of the upper limb | Participants are adult patients aged 18-65 years, both male and female, classified as ASA II-VI, and scheduled for elective superficialization procedures (mainly AV fistula superficialization). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perfusion Index ratio
Change in Perfusion Index ratio at 15 minutes after supraclavicular brachial plexus block in predicting successful block
Measured: 15 minutes
Change in End Diastolic Velocity ratio
Change in End Diastolic Velocity ratio at 15 minutes after supraclavicular brachial plexus block in predicting successful block
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 May 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Diastolic VelocityStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abubakr Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197281
- Sponsor's protocol ID
- PI and EDV as Predictors
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
PubMed 28854539
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Perfusion Index Ratio and End Diastolic Velocity Ratio After Supraclavicular Brachial Plexus Block as an Early Predictor of Successful Block in Superficialization Surgery of the Upper Limb
- ClinicalTrials.gov ID
- NCT07197281
- Acronym / sponsor ID
- PI and EDV as Predictors
- Conditions
- End Diastolic Velocity, Perfusion Index
- Keywords
- End Diastolic Velocity, brachial plexus block, Perfusion Index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (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.
This is a prospective observational study investigating the correlation between Perfusion Index (PI) ratio and End Diastolic Velocity (EDV) ratio as early predictors of successful supraclavicular brachial plexus block (SCBPB) in patients undergoing superficialization surgery of the upper limb.
Detailed description
Regional anesthesia is fundamental for upper limb surgeries, with SCBPB providing dense anesthesia. However, early confirmation of successful block performance remains challenging. Traditional clinical methods (sensory/motor testing) are subjective and delayed. This study proposes using objective, noninvasive indices - PI (evaluated via pulse oximetry) and EDV (measured by Doppler ultrasound) - to determine their accuracy in detecting sympathetic blockade shortly after SCBPB. Early and reliable detection of block success is particularly important in superficialization surgeries such as arteriovenous fistula (AVF) superficialization in patients with compromised vascular status. The results are expected to enhance anesthesia practice by providing quantitative, reproducible, and rapid assessment tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients scheduled for elective superficialization surgery of the upper limb | – | –Participants are adult patients aged 18-65 years, both male and female, classified as ASA II-VI, and scheduled for elective superficialization procedures (mainly AV fistula superficialization). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are adult patients aged 18-65 years, both male and female, classified as ASA II-VI, and scheduled for elective superficialization procedures (mainly AV fistula superficialization). Patients must be capable of understanding and signing informed consent. Excluded are patients with contraindications to nerve block such as coagulopathy, local infection, allergy to local anesthetics, severe vascular disease, morbid obesity (BMI >35), severe neurological or psychiatric impairment, or those taking vasopressors or beta-blockers that could alter vascular reactivity.
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Both genders
- ASA II-VI classification
- Undergoing elective upper limb superficialization surgery (e.g., AVF superficialization)
- Provided written informed consent
Key exclusion criteria (8 listed)
- Patient refusal
- Coagulopathy or bleeding disorders
- Local infection at injection site
- Allergy to local anesthetics
- Use of vasopressors or beta-blockers
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
Change in Perfusion Index ratio
Time frame: 15 minutes
Change in Perfusion Index ratio at 15 minutes after supraclavicular brachial plexus block in predicting successful block
Change in End Diastolic Velocity ratio
Time frame: 15 minutes
Change in End Diastolic Velocity ratio at 15 minutes after supraclavicular brachial plexus block in predicting successful block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Background: PubMed 28854539Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of End Diastolic Velocity and Perfusion Index, run by Assiut University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Perfusion Index ratio (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07197281, which also lists 1 linked publication.
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 29 Sep 2025.