Trials / Completed
CompletedNCT05892367
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease
Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease: Evaluation of Local Complications With or Without Post-interventional Immobilization of the Upper Extremity
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Wilhelminenspital Vienna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.
Detailed description
Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion. Due to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm. Following the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery. This examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Transbrachial Access for Interventions | Adding a positioning splint in addition to compression bandage after intervention in order to guarantee immobilization of puncture site |
Timeline
- Start date
- 2018-07-10
- Primary completion
- 2020-08-21
- Completion
- 2020-10-02
- First posted
- 2023-06-07
- Last updated
- 2023-06-07
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT05892367. Inclusion in this directory is not an endorsement.