Ultrasound Guided Arterial Puncture

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01660724
• Collaborator: (none)
• Enrollment: 238
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Puncture	Procedure: Ultrasound guided arterial puncture; Procedure: Conventional arterial puncture technique	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 238 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Official Title: Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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	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
Active Comparator: Conventional arterial puncture technique Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique	Procedure: Conventional arterial puncture technique; Arterial puncture is performed using the conventional technique

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Time used for arterial puncture [up to 1 hour after arterial puncture]

2. Patient corporation [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.

3. Pain Scores on the Visual Analog Scale [Up to 1 hour after arterial puncture]

4. Number of attempts before successfully acquiring arterial puncture [up to 1 hour after arterial puncture]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense	Fyn	Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Christian B Laursen, MD, Odense Universityhospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Christian Borbjerg Laursen, Principal investigator, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT01660724
• Other Study ID Numbers: Mulvarp2012
• First Posted: Aug 9, 2012
• Last Update Posted: Aug 5, 2013
• Last Verified: Aug 1, 2013

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Aug 5, 2013