Circulatory; ChangeNCT02727829
The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time
An observational study of Circulatory; Change, run by Tokat Gaziosmanpasa University.
Trial summary
The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Circulatory; Change
- What is being tested?
- pefusion index measurement
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Oct 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * American Society of Anesthesiologists score of I and III * ages between 18 and 70 * upper extremity surgery
Who may be able to join
- American Society of Anesthesiologists score of I and III
- ages between 18 and 70
- upper extremity surgery
Who cannot join
- not to participate in the study
- reject to perform the intervention
- infection in injection cite
- allergy to local anesthetics
- peripherical vasculary diseases
- psychiatric diseases
- coagulation anomalies
About this study
The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time.
Read the detailed description
Microcirculation is very crucial to evaluate the organ function those working properly in human body. The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time. A total of 50 patients whose planned to underwent surgery are performed brachial plexus block using ultrasound, and pefusion index, heart rate, blood pressure, capillary filling time are measured at 0, 10th and 20th minutes interval and at postoperative 24th hours. All measures will be recorded.
- Conditions
- Circulatory; Change
- Being tested
- pefusion index measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pefusion index measurementDevice
perfusion index measurement using massimo radical 7 device
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
Measured: five times in one year
Secondary outcomes (4)
capillary filing time
Measured: five times in one year
heart rate
Measured: five times in one year
blood pressure
Measured: five times in one year
oxygen saturation
Measured: five times in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start1 May 2016
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory; ChangeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, humeyra astan, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727829
- Sponsor's protocol ID
- 15-KAEK-221
- Status last verified
- Feb 2017
- First submitted
- 30 Mar 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Microcirculation in Brachial Plexus Block Using Perfusion Index and Capillary Filling Time
- ClinicalTrials.gov ID
- NCT02727829
- Acronym / sponsor ID
- 15-KAEK-221
- Conditions
- Circulatory; Change
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 5 Apr 2016 (estimated)
- 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.
The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time.
Detailed description
Microcirculation is very crucial to evaluate the organ function those working properly in human body. The aim of the present study is to assess the effects of brachial plexus block on microcirculation using pefusion index and capillary filling time. A total of 50 patients whose planned to underwent surgery are performed brachial plexus block using ultrasound, and pefusion index, heart rate, blood pressure, capillary filling time are measured at 0, 10th and 20th minutes interval and at postoperative 24th hours. All measures will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * American Society of Anesthesiologists score of I and III * ages between 18 and 70 * upper extremity surgery
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists score of I and III
- ages between 18 and 70
- upper extremity surgery
Key exclusion criteria (7 listed)
- not to participate in the study
- reject to perform the intervention
- infection in injection cite
- allergy to local anesthetics
- peripherical vasculary diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pefusion index measurementperfusion index measurement using massimo radical 7 device | Device | – |
Primary outcome
perfusion index
Time frame: five times in one year
4 secondary outcomes
capillary filing time
Time frame: five times in one year
heart rate
Time frame: five times in one year
blood pressure
Time frame: five times in one year
oxygen saturation
Time frame: five times in one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- 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. This study is not recruiting at the moment.
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 Circulatory; Change, run by Tokat Gaziosmanpasa 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 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: finished, as of the sponsor's last update on 14 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: five times in one year). 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 14 Feb 2017.