Clinical trial NCT01785225: Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
Official title: Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasound
Sterile Puncture Area
Blood Sampling
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2013-02-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of successful blood withdrawals
timeFrame: During blood sampling
Secondary outcomes:
measure: Image quality with and without sterile cover
timeFrame: During blood sampling
Other outcomes:
measure: Number of skin penetrations needed to puncture the vein
timeFrame: During blood sampling
measure: Unexpected difficulties with the sterilization procedure
timeFrame: during blood sampling
measure: Number of posterior vessel wall punctures
timeFrame: during blood sampling
measure: Time spent from tourniquet is placed to blood withdrawals
timeFrame: during blood sampling
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby
Study officials:
affiliation: Aarhus University Hospital
name: Erik Sloth, Professor, MD
role: STUDY_DIRECTOR
References: