NCT01690416

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 12, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

September 13, 2012

Last Update Submit

May 11, 2015

Conditions

Disorder of Cardiac Function

Outcome Measures

Primary Outcomes (4)

  • Attempts

    The number of attempts (skin punctures) per catheterization

    1 hour

  • Withdrawals

    The number of withdrawals of the guide-needle per catheterization

    1 hour

  • Time consume

    The time spend for the catheterization procedure

    minutes

  • Catheters

    The number of utilized catheters

    1 hour

Secondary Outcomes (2)

  • pain

    momentan

  • Ease of method for the operator

    momentan

Study Arms (2)

Ultrasound DNTP

ACTIVE COMPARATOR

the catheter will be placed using ultrasound and DNTT and Lidocaine as local anesthesia, by the same fellow as the one who performs the puncture with the traditional method

Procedure: Traditional palpation techniqueProcedure: Ultrasound DNTP

Traditional palpation technique

ACTIVE COMPARATOR

arteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow

Procedure: Traditional palpation techniqueProcedure: Ultrasound DNTP

Interventions

Traditional palpation techniquePROCEDURE
Traditional palpation techniqueUltrasound DNTP
Ultrasound DNTPPROCEDURE
Traditional palpation techniqueUltrasound DNTP

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
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 compromised flow in either the radial or ulnar artery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Universitets Hospital

Aarhus, Jylland, 8200, Denmark

Location

Study Officials

  • Marlene Aa Hansen, stud.med

    Anæstesiologisk-Intensiv afd I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stud.med

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 12, 2015

Record last verified: 2015-05

Locations

DK(1)