Upper Extremity SurgeryNCT05234541
Measurement of Cut-off Perfusion Index Value in Infraclavicular Blocks
An observational study of Upper Extremity Surgery, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Extremity Surgery
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 15 Nov 2022
- How long will I take part?
- 2 Months
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA1-2 50 PATIENTS BETWEEN 18-65 YEARS
Who may be able to join
- ASA 1-2 PATIENTS
- PATIENTS BETWEEN 18-65 YEARS
- PATIENTS WITH INFRACLAVICULAR BLOCK
Who cannot join
- ASA3-4 PATIENTS
- PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65
- PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY
- PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK
- PATIENTS WITHOUT COOPERATION
- PATIENTS WITH DIABETES MELLITUS
- THOSE WHO HAVE PERIPHERAL ARTERY DISEASE
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance.
To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.
Read the detailed description
In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.
- Conditions
- Upper Extremity Surgery
- Keywords
- infraclavicular block, perfusion index
What is being measured
The primary outcome is the main question the study is designed to answer.
To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance
To measure perfusion index values in patients aged 18-65 years who underwent upper extremity surgery
Measured: Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jul 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity SurgeryStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEHMET DURAN, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234541
- Sponsor's protocol ID
- 2020/6-18
- Other IDs
- ISEYHANLI
- Status last verified
- Jul 2021
- First submitted
- 1 Feb 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance.
- ClinicalTrials.gov ID
- NCT05234541
- Acronym / sponsor ID
- 2020/6-18
- Conditions
- Upper Extremity Surgery
- Keywords
- infraclavicular block, perfusion index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 10 Feb 2022 (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.
To investigate the value of the cut-off perfusion index showing that the block is successful in infraclavicular blocks performed under ultrasound guidance.
Detailed description
In upper extremity procedures, ultrasound (US) guided infraclavicular block is a frequently used approach. Today, the frequency of studies on the perfusion index (PI), which can be used as a criterion in the evaluation of block success, is increasing. The aim of this study is to evaluate the success and effectiveness of infraclavicular approach block with perfusion index using ROC (Receiver Operating Characteristic) curves.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA1-2 50 PATIENTS BETWEEN 18-65 YEARS
Key inclusion criteria (3 listed)
- ASA 1-2 PATIENTS
- PATIENTS BETWEEN 18-65 YEARS
- PATIENTS WITH INFRACLAVICULAR BLOCK
Key exclusion criteria (7 listed)
- ASA3-4 PATIENTS
- PATIENTS UNDER THE AGE OF 18, PATIENTS OVER 65
- PATIENTS WHO DO NOT WANT TO BE INCLUDED IN THE STUDY
- PATIENTS WITH CONTRAINDICATION TO INFRACLAVICULAR BLOCK
- PATIENTS WITHOUT COOPERATION
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
To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance
Time frame: Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made.
To measure perfusion index values in patients aged 18-65 years who underwent upper extremity surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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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 Upper Extremity Surgery, run by Adiyaman University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 10 Feb 2022. 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 Turkey (Türkiye). 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?
To Investigate the Value of the Cut-off Perfusion Index Showing That the Block is Successful in Infraclavicular Blocks Performed Under Ultrasound Guidance (time frame: Perfusion index, pulse and blood pressure will be measured 5-10-20 minutes after the block is made.). 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 10 Feb 2022.