An interventional study of Ultrasound guided sheath insertion in Radial, Angioplasty and Angiography, sponsored by Christian Juhl Terkelsen. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Christian Juhl Terkelsen · Not applicable, Interventional, and Diagnostic
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.
Christian Juhl Terkelsen is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound guided sheath insertion
Diagnostic Test: Ultrasound guided sheath insertion
Conventional arm during randomized phase
Conventional arm, non-randomization phase
ultrasound is used routinely for sheath insertion
number of puncture attempts
Number of attempts to puncture the vessel as evaluated by the physician and by go-pro camera recordings
Time frame: during the procedure
time of procedure
time from administration of analgetics to removal of the sheath
Time frame: 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
Time frame: during the procedure
Pain during sheath insertion and during the procedure
Pain according to numerical rating scale during sheath insertion and during the procedure
Time frame: 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)
Time frame: during the procedure
Use of analgetics
Cummulated dose of analgetics during the procedure
Time frame: during the procedure
Use of sedatives
Cummulated dose of sedatives during the procedure
Time frame: during the procedure
Use of calcium blocker
Cummulated dose of calcium blocker during the procedure
Time frame: during the procedure
Radial artery patency
Patency according to reverse Barbeau test at time of sheath removal
Time frame: during the procedure
Plan to share: No — Anonymous data can be shared
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Christian Juhl Terkelsen