Radiation Exposure and Operator Musculoskeletal Strain in Endovascular Aortic Repair: a Randomized Trial of Exoskeleton vs. Standard Aprons
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors.
Study Overview
Brief Summary
The goal of this clinical trial is to learn whether an exoskeleton-supported radiation protection system can reduce radiation exposure and musculoskeletal strain in vascular surgeons during endovascular aortic repair procedures, compared with standard lead aprons. Researchers will compare procedures performed with exoskeleton-supported protection and procedures performed with standard lead aprons. Radiation exposure, physical strain, fatigue, and discomfort will be assessed during and after procedures.
Detailed Description
This is a prospective, randomized, controlled crossover study evaluating an exoskeleton-supported radiation protection system versus standard lead aprons during complex endovascular aortic repair procedures. The study will be conducted at the Department of Vascular Surgery, University Clinical Hospital No. 2 in Szczecin, Pomeranian Medical University.
Two vascular surgeons will participate in the study and perform a total of 60 procedures, including EVAR, IBD-EVAR, and BEVAR. Before each procedure, the type of radiation protection will be randomly assigned: a standard lead apron or an exoskeleton-supported protective system with visor. Each procedure will be performed in full with the assigned protection system, without switching during the intervention.
Operator radiation exposure will be measured in real time using 3 personal dosimeters per operator. Musculoskeletal load will be assessed using shoulder load sensors. After each procedure, operators will complete standardized questionnaires evaluating fatigue and discomfort, including the Borg CR-10 scale, visual analog scale, and Nordic Questionnaire.
The primary objective is to determine whether the exoskeleton-supported protection system reduces operator radiation exposure and musculoskeletal strain during endovascular aortic repair procedures. The results may help improve occupational safety during complex fluoroscopy-guided vascular interventions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 35 years or older
- •written informed consent obtained
- •vascular surgeon with substantial experience in endovascular procedures
- •active participation in endovascular aortic repair procedures as a primary operator or assistant
- •high procedural volume in endovascular interventions
Exclusion Criteria
- •refusal or inability to provide informed consent
- •medical contraindications to the use of standard lead aprons or the exoskeleton-supported radiation protection system
- •health conditions preventing safe participation in study procedures
Arms & Interventions
Exoskeleton-Supported Protection System
Endovascular aortic repair procedures performed with an exoskeleton-supported radiation protection system with visor.
Intervention: Exoskeleton-supported radiation protection system (Device)
Standard Lead Apron
Endovascular aortic repair procedures performed with standard lead apron radiation protection.
Intervention: Standard lead apron (Device)
Outcomes
Primary Outcomes
Operator musculoskeletal strain assessed during endovascular aortic repair procedures using shoulder load sensors.
Time Frame: During each procedure
Operator weight distribution and physical load assessed during endovascular aortic repair procedures using foot-mounted load sensors.
Operator radiation exposure
Time Frame: During each procedure
Operator radiation exposure measured during endovascular aortic repair procedures using real-time personal dosimetry.
Secondary Outcomes
No secondary outcomes reported