Peripheral Artery Occlusive DiseaseNCT05737225
Regional Anesthesia for Percutaneous Transluminal Angioplasty
An observational study of Peripheral Artery Occlusive Disease and Percutaneous Transluminal Angioplasty, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of regional anesthesia method applied in patients who will undergo percutaneous transluminal angioplasty for lower extremity revascularization will be investigated comparatively. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Occlusive Disease, Percutaneous Transluminal Angioplasty
- What is being tested?
- Near Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2022to 1 May 2023
- How long will I take part?
- 1 Day
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA I-III patients over the age of 18 who have been decided to perform elective PTA as a treatment method for peripheral arterial disease will be included in the study.
Who may be able to join
- Age: > 18 years
- Peripheral artery occlusive disease
- Eligibility for PTA
Who cannot join
- Patients' refusal
- Under the age of 18
- Language problems (not knowing turkish)
- Psychological or mental disorders.
- Disturbance of Conscious level.
- Uncooperative patients
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- Those who are allergic to anesthetic drugs to be used
- Those with contraindications for the application of peripheral nerve block (coagulopathy, skin infection at the block site)
- need for endotracheal intubation or general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Regional Anesthesia Method on Tissue Oxygenation in Patients Who Will Undergo Percutaneous Transluminal Angioplasty
In this study, the effects of regional anesthesia method applied in patients who will undergo percutaneous transluminal angioplasty for lower extremity revascularization will be investigated comparatively.
- Being tested
- Near Infrared Spectroscopy (NIRS)
- Keywords
- percutaneous transluminal angioplasty, tissue oxygenation
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal sciatic nerve block group | regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure Receives: Device: Near Infrared Spectroscopy (NIRS) | |
| Control group | patients who will undergo percutaneous transluminal angioplasty (PTA) procedure Receives: Device: Near Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue Oxygenation
Tissue oxygenation will be measured from both lower extremities by Near Infrared Spectroscopy for 30 min after popliteal sciatic nerve block and during procedure.
Measured: During procedure
Secondary outcomes (3)
Body Temperature of Lower Extremities
Body temperature will be measured simultaneously at 0-5-10-15-20-25 and 30th minutes after the application of the popliteal sciatic nerve block
Measured: During procedure
Patient Satisfaction Score
Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.
Measured: 15 minutes after procedure
Surgeon Satisfaction Score
Self-administrated satisfaction score will be collected with scale from 0 to 5. A score of "0" means extremely dissatisfied and that a score of "5" means extremely satisfied.
Measured: 15 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start24 Sep 2022
- Primary completion17 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Coşkun, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737225
- Sponsor's protocol ID
- 775 (24.10.2022)
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Anesthesia Method on Tissue Oxygenation in Patients Who Will Undergo Percutaneous Transluminal Angioplasty
- ClinicalTrials.gov ID
- NCT05737225
- Acronym / sponsor ID
- 775 (24.10.2022)
- Keywords
- percutaneous transluminal angioplasty, tissue oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 17 Apr 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Feb 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.
In this study, the effects of regional anesthesia method applied in patients who will undergo percutaneous transluminal angioplasty for lower extremity revascularization will be investigated comparatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Popliteal sciatic nerve block group | – | Device: Near Infrared Spectroscopy (NIRS)regional anesthesia applied patients who will undergo percutaneous transluminal angioplasty (PTA) procedure |
| Control group | – | Device: Near Infrared Spectroscopy (NIRS)patients who will undergo percutaneous transluminal angioplasty (PTA) procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-III patients over the age of 18 who have been decided to perform elective PTA as a treatment method for peripheral arterial disease will be included in the study.
Key inclusion criteria (3 listed)
- Age: > 18 years
- Peripheral artery occlusive disease
- Eligibility for PTA
Key exclusion criteria (9 listed)
- Patients' refusal
- Under the age of 18
- Language problems (not knowing turkish)
- Psychological or mental disorders.
- Disturbance of Conscious level.
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 |
|---|---|---|
| Near Infrared Spectroscopy (NIRS)We will place Near Infrared Spectroscopy (NIRS) electrode on the foot to evaluate regional tissue oxygen saturation in both lower extremities before the performing regional anesthesia (popliteal sciatic nerve block) and then during the procedure. | Device | Control group, Popliteal sciatic nerve block group |
Primary outcome
Tissue Oxygenation
Time frame: During procedure
Tissue oxygenation will be measured from both lower extremities by Near Infrared Spectroscopy for 30 min after popliteal sciatic nerve block and during procedure.
3 secondary outcomes
Body Temperature of Lower Extremities
Time frame: During procedure
Patient Satisfaction Score
Time frame: 15 minutes after procedure
Surgeon Satisfaction Score
Time frame: 15 minutes after procedure
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 20 Dec 2023.
- 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.
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 Peripheral Artery Occlusive Disease and Percutaneous Transluminal Angioplasty, run by Gazi 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 9 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 20 Dec 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 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?
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?
Tissue Oxygenation (time frame: During procedure). 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 20 Dec 2023.