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slow recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound arm - Randomized group | Experimental | Ultrasound guided sheath insertion |
|
| Conventional arm - Randomized group | No Intervention | Conventional arm during randomized phase | |
| Historical control group | No Intervention | Conventional arm, non-randomization phase |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided sheath insertion | Diagnostic Test | ultrasound is used routinely for sheath insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of puncture attempts | Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings | during the procedure |
| time of procedure | time from administration of analgetics to removal of the sheath | during the procedure |
| Placement of sheath | Distance from proc.styloideus radius (radial procedure) or proximal part of caput femoris (femoral procedure) to vessel puncture site evaluated by angiography | during the procedure |
| Pain during sheath insertion and during the procedure | Pain according to numerical rating scale during sheath insertion and during the procedure | during the procedure |
| Successfull 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) | during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Use of analgetics | Cummulated dose of analgetics during the procedure | during the procedure |
| Use of sedatives | Cummulated dose of sedatives during the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| erik sloth, professor | Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology, Aarhus University Hospital in Skejby | Aarhus | 8200 | Denmark |
Anonymous data can be shared
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historical control cohort (Group A) and then a randomized prospective study (Group B and C).
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| during the procedure |
| Use of calcium blocker | Cummulated dose of calcium blocker during the procedure | during the procedure |
| Radial artery patency | Patency according to reverse Barbeau test at time of sheath removal | during the procedure |