NCT01561196

Brief Summary

The aim of the project is to compare two methods for arterial cannulation. The traditional method with ultrasound guided cannulation. The investigators goal is to improve this procedure to reduce pain and complications.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

10 months

First QC Date

March 13, 2012

Last Update Submit

January 30, 2013

Conditions

Heart Disease

Keywords

arteria cannulationUltrasoundpaincomplications

Outcome Measures

Primary Outcomes (1)

  • Pain score on visual analog scale

    The primary outcome is the subjective feeling of pain following the two methods.

    5 minutes

Secondary Outcomes (4)

  • Time spend on the procedure

    1 day

  • Number of utilized needles

    1 day

  • number of pricks

    1 day

  • number of withdrawals

    1 day

Study Arms (2)

Ultrasound guided arterial cannulation

ACTIVE COMPARATOR

The arterial needle is placed using ultrasound monitoring for guiding the operator.

Procedure: arterial catheterisation

Conventional cannulation

ACTIVE COMPARATOR

the arterial needle is placed using the traditional method and lidocaine. The operator decides where to place the needle in the forearm

Procedure: arterial catheterisation

Interventions

arterial catheterisationPROCEDURE

arterial catheterisation in Arterial Radialis

Also known as: ICD10 I95.9
Conventional cannulationUltrasound guided arterial cannulation

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-90 years
  • Fulfill the criteria of an operation
  • Routine need of an arterial needle

You may not qualify if:

  • Lack of patient consent
  • Ultrasound identified plaques in the radial artery or ultrasound verified positive Allens test or traditional positive Allens test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anæstesiologisk-Intensiv afdeling I

Aarhus, Jylland, 8200, Denmark

Location

Related Links

MeSH Terms

Conditions

Heart DiseasesPain

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marlene Aa Hansen, stud.med

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
stud.med

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 22, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

DK(1)