Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area

Not Applicable

• Conditions: Ultrasound; Sterile Puncture Area; Blood Sampling
• Interventions: Device: A product type of the modified commercial drape Tegaderm (R)

• Registration Number: NCT01785225
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Thousands of vein punctures are done every day at hospitals worldwide. Vein puncture are performed in connection with blood sampling, peripheral intravenous catheter (PIV) placement or blood donation. The predominantly used venous for blood withdraw are in the cubital region because in this area venous are most superficial placed and most often visible for the human eye. However, when using the usual blind landmark and palpation method in this region, it often proves exceedingly difficult or even impossible to obtain peripheral venous access on patients who are obese, chronically ill, hypovolemic or intravenous drug users. Various studies have shown that the success rate for establishing a vascular access with ultrasound compared to blind landmark technique is higher in patients with difficult access. When ultrasound is used to establish intravascular access, the prerequisite sterile puncture area can be challenging to meet due to ultrasound gel on the area and the fact that the ultrasound transducer cannot be wiped clean with alcohol after being in contact with a patient's skin or blood. A strict sterile procedure is important to reduce complications related to infection.The traditional way of coping with this is by covering the transducer and the wire in a long sterile sheet and using sterile gel. The sheet must be tight with rubber band around the transducer and pulled tightly around the transducer foot to prevent artefacts from appearing on the screen. This is an expensive and time consuming method, and it still leaves the problem with gel in the puncture area.

The investigators have developed a method by where all these problems are solved by using, a slightly modified, commercial drape in combination with the Dynamic Needle Tip Positioning technique

The investigators hypothesize that it is possible to perform ultrasound-guided venous puncture with a sterile and dry puncture area and that puncture can be performed proximal and distal to the traditional puncture side.

It is a procedure presenting study that serves to demonstrate the feasibility of the method in ten healthy volunteers. The study will take place at Aarhus University Hospital, Skejby.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-02
• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-05
• Last Update Submitted: 2013-02-05
• Study First Posted: 2013-02-07
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• age between 18 and 70 years of age
• mentally competent
• of good health

Exclusion Criteria

• age below 18 or above 70 years of age
• daily use of blood thinner medication
• suffering from a chronic illness that requires frequent blood withdrawals
• heart conditions or vascular diseases
• People known to experience vasovagal episodes when having blood samples taken

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
modified commercial drape Tegaderm (R)	A product type of the modified commercial drape Tegaderm (R)	-

Primary Outcome Measures

Name	Time	Method
Number of successful blood withdrawals	During blood sampling

Secondary Outcome Measures

Name	Time	Method
Image quality with and without sterile cover	During blood sampling

Trial Locations

Locations (1)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark