Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty

NCT03060460 | Terminated DMC

• 1 other identifier: ACCESS-II
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radial; Angioplasty; Angiography; Ultrasound; Randomized

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Use of analgetics

  during the procedure

• Use of sedatives

  during the procedure

• Use of calcium blocker

  during the procedure

• Radial artery patency

  during the procedure

Study Arms (3)

Ultrasound arm - Randomized group

EXPERIMENTAL

Ultrasound guided sheath insertion

Diagnostic Test: 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

Interventions

Ultrasound guided sheath insertion DIAGNOSTIC_TEST

ultrasound is used routinely for sheath insertion

Ultrasound arm - Randomized group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for angiography or angioplasty in whom both radial and femoral access is possible

You may not qualify if:

• Abnormal pulse oxymetry test
• If severe lower-extremity calcification is known to exclude femoral access

Sponsors & Collaborators

• Christian Juhl Terkelsen: lead

Study Sites (1)

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

Location

Study Officials

• erik sloth, professor

  Department of anaestesiology, Aarhus University Hospital, DK-8200 Aarhus N

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: historical control cohort (Group A) and then a randomized prospective study (Group B and C).

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 23, 2017
• Study Start: April 26, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)