Angiography, Angioplasty, Radial, Randomized, Ultrasound
Conditions
Brief summary
The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.
Detailed description
A randomised study with an historical control group. Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures). Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
Interventions
DIAGNOSTIC_TESTUltrasound guided sheath insertion
ultrasound is used routinely for sheath insertion
Sponsors
Christian Juhl Terkelsen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
historical control cohort (Group A) and then a randomized prospective study (Group B and C).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible
Exclusion criteria
* Abnormal pulse oxymetry test * If severe lower-extremity calcification is known to exclude femoral access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successfull procedure | during the procedure | Proportion of patients where the procedure is completed according to prespecified access route (no conversion to femoral access if radial planned, and no conversion to radial access if femoral planned) |
| number of puncture attempts | during the procedure | Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings |
| time of procedure | during the procedure | time from administration of analgetics to removal of the sheath |
| Placement of sheath | during the procedure | Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography |
| Pain during sheath insertion and during the procedure | during the procedure | Pain according to numerical rating scale during sheath insertion and during the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of sedatives | during the procedure | Cummulated dose of sedatives during the procedure |
| Use of calcium blocker | during the procedure | Cummulated dose of calcium blocker during the procedure |
| Radial artery patency | during the procedure | Patency according to reverse Barbeau test at time of sheath removal |
| Use of analgetics | during the procedure | Cummulated dose of analgetics during the procedure |
Countries
Denmark
Outcome results
None listed