NCT01660724

Brief Summary

The main purpose of the study is to evaluate whether the routine use of ultrasound guided arterial puncture can increase the proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis, when ultrasound guided arterial puncture is compared to conventional arterial puncture technique.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

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

July 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

1.1 years

First QC Date

July 16, 2012

Last Update Submit

August 2, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis

    up to 1 hour after arterial puncture

Secondary Outcomes (4)

  • Time used for arterial puncture

    up to 1 hour after arterial puncture

  • Patient corporation

    up to 1 hour after arterial puncture

  • Pain Scores on the Visual Analog Scale

    Up to 1 hour after arterial puncture

  • Number of attempts before successfully acquiring arterial puncture

    up to 1 hour after arterial puncture

Study Arms (2)

Ultrasound guided arterial puncture

EXPERIMENTAL

Patients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery

Procedure: Ultrasound guided arterial puncture

Conventional arterial puncture technique

ACTIVE COMPARATOR

Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique

Procedure: Conventional arterial puncture technique

Interventions

Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery

Ultrasound guided arterial puncture

Arterial puncture is performed using the conventional technique

Conventional arterial puncture technique

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient admitted or treated in the acute emergency department
  • Indication for a arterial blood gas analysis, according to the physician responsible for the patient's hospital stay / treatment

You may not qualify if:

  • Patient age \< 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

Related Publications (1)

  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

Study Officials

  • Christian B Laursen, MD

    Odense Universityhospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 16, 2012

First Posted

August 9, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations