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Ultrasound Guided Arterial Puncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01660724
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : August 5, 2013
Sponsor:
Information provided by (Responsible Party):
Christian Borbjerg Laursen, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE July 16, 2012
First Posted Date  ICMJE August 9, 2012
Last Update Posted Date August 5, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2012)
The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis [ Time Frame: up to 1 hour after arterial puncture ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2012)
  • Time used for arterial puncture [ Time Frame: up to 1 hour after arterial puncture ]
  • Patient corporation [ Time Frame: up to 1 hour after arterial puncture ]
    Patient corporation is subjectively estimated by the physician performing the arterial puncture. The degree of patient corporation are assessed on a scale from 1 - 5, where 1 is very poor patient corporation and 5 is perfect patient corporation.
  • Pain Scores on the Visual Analog Scale [ Time Frame: Up to 1 hour after arterial puncture ]
  • Number of attempts before successfully acquiring arterial puncture [ Time Frame: up to 1 hour after arterial puncture ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided Arterial Puncture
Official Title  ICMJE Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Condition  ICMJE Arterial Puncture
Intervention  ICMJE
  • Procedure: Ultrasound guided arterial puncture
    Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
  • Procedure: Conventional arterial puncture technique
    Arterial puncture is performed using the conventional technique
Study Arms  ICMJE
  • Experimental: Ultrasound guided arterial puncture
    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
    Intervention: Procedure: Ultrasound guided arterial puncture
  • Active Comparator: Conventional arterial puncture technique
    Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique
    Intervention: Procedure: Conventional arterial puncture technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2012)
238
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient age < 16 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01660724
Other Study ID Numbers  ICMJE Mulvarp2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christian Borbjerg Laursen, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christian B Laursen, MD Odense Universityhospital
PRS Account Odense University Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP