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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01785225
Enrollment
10
Registered
2013-02-07
Start date
2013-02-28
Completion date
2013-03-31
Last updated
2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Sampling, Sterile Puncture Area, Ultrasound

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.

Interventions

DEVICEA product type of the modified commercial drape Tegaderm (R)

We test if a product type of the modified commercial drape Tegaderm(R) can bee used when taking blood samples under the guidance af ultrasound. The drape is used to keep the puncture area sterile and clean of ultrasound gel.

Sponsors

Danish Cancer Society
CollaboratorOTHER
Aarhus University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of successful blood withdrawalsDuring blood sampling

Secondary

MeasureTime frame
Image quality with and without sterile coverDuring blood sampling

Other

MeasureTime frameDescription
Number of skin penetrations needed to puncture the veinDuring blood sampling
Unexpected difficulties with the sterilization procedureduring blood samplingDoes the Tegaderm (R) device provide adequate protection so no gel will get into the puncture area? Is it possible to move the probe as the operator desires despite of the Tegaderm (R) device?
Number of posterior vessel wall puncturesduring blood sampling
Time spent from tourniquet is placed to blood withdrawalsduring blood sampling

Countries

Denmark

Contacts

Primary ContactSofie Thorn, student
thorn@studmed.au.dk0045 61711623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026