Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease
- Conditions
- Complication of Treatment
- Interventions
- Other: Transbrachial Access for Interventions
- Registration Number
- NCT05892367
- Lead Sponsor
- Wilhelminenspital Vienna
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)
- age > 18 years
- approval to participate
- unability or refusal to participate
- dialysis patients/AV-fistula interventions
- usage of closure devices
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group Transbrachial Access for Interventions Application of a compression bandage and a positioning splint following transbrachial puncture for 24 hours Control group Transbrachial Access for Interventions Application of a compression bandage following transbrachial puncture for 24 hours
- Primary Outcome Measures
Name Time Method Occurrence of local complications at the puncture site 6 weeks Local complications as hematoma, bleeding, pseudoaneurysm, arterial dissection, arterial stenosis, arterial occlusion, AV fistula detected by ultrasound 24 hours after intervention and at time of follow-up six weeks after treatment
- Secondary Outcome Measures
Name Time Method Post-interventional pain at puncture site 24 hours Evaluation of local pain according to V.A.S. score by asking patients after intervention
Trial Locations
- Locations (1)
Department of Vascular and Endovascular Surgery
🇦🇹Vienna, Austria