Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

Conditions
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Radial, Angioplasty, Angiography, Ultrasound, Randomized

Intervention / Treatment
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* Diagnostic Test: Ultrasound guided sheath insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: historical control cohort (Group A) and then a randomized prospective study (Group B and C).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound arm - Randomized group<br>Ultrasound guided sheath insertion | Diagnostic Test: Ultrasound guided sheath insertion<br>* ultrasound is used routinely for sheath insertion<br>|
| No Intervention: Conventional arm - Randomized group<br>Conventional arm during randomized phase | |
| No Intervention: Historical control group<br>Conventional arm, non-randomization phase | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |