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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01660724
Other study ID # Mulvarp2012
Secondary ID
Status Completed
Phase N/A
First received July 16, 2012
Last updated August 2, 2013
Start date July 2012
Est. completion date August 2013

Study information

Verified date August 2013
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 238
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


Intervention

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
Conventional arterial puncture technique
Arterial puncture is performed using the conventional technique

Locations

Country Name City State
Denmark Odense University Hospital Odense Fyn

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Time used for arterial puncture up to 1 hour after arterial puncture No
Secondary Patient corporation 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. up to 1 hour after arterial puncture No
Secondary Pain Scores on the Visual Analog Scale Up to 1 hour after arterial puncture No
Secondary Number of attempts before successfully acquiring arterial puncture up to 1 hour after arterial puncture No
See also
  Status Clinical Trial Phase
Recruiting NCT05841836 - The Safety and Efficacy of the Suture-Mediated Closure System N/A