Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty (ACCESS-II)

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

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.

Study Overview

• Status: Terminated
• Conditions: Randomized; Ultrasound; Angioplasty; Angiography; Radial
• Intervention / Treatment: Diagnostic test: Ultrasound guided sheath insertion

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of cardiology, Aarhus University Hospital in Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Christian Juhl Terkelsen
• Investigators: Study Chair: erik sloth, professor, Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 18, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ACCESS-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymous data can be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No