Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

Ultrasound Clinical Trial

— ACCESS-II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03060460
• Other study ID #: ACCESS-II
• Status: Terminated
• Phase: N/A
• Start date: April 26, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiography
• Angioplasty
• Radial
• Randomized
• Ultrasound

Intervention

Diagnostic Test:
• Ultrasound guided sheath insertion
ultrasound is used routinely for sheath insertion

Locations

Country	Name	City	State
Denmark	Department of cardiology, Aarhus University Hospital in Skejby	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Christian Juhl Terkelsen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	time of procedure	time from administration of analgetics to removal of the sheath	during the procedure
Primary	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
Primary	Pain during sheath insertion and during the procedure	Pain according to numerical rating scale during sheath insertion and during the procedure	during the procedure
Primary	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	Use of analgetics	Cummulated dose of analgetics during the procedure	during the procedure
Secondary	Use of sedatives	Cummulated dose of sedatives during the procedure	during the procedure
Secondary	Use of calcium blocker	Cummulated dose of calcium blocker during the procedure	during the procedure
Secondary	Radial artery patency	Patency according to reverse Barbeau test at time of sheath removal	during the procedure