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

NCT01785225 | Unknown DMC

• 1 other identifier: 1-10-72-589-12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasound; Sterile Puncture Area; Blood Sampling

Outcome Measures

Primary Outcomes (1)

• Number of successful blood withdrawals

  During blood sampling

Secondary Outcomes (1)

• Image quality with and without sterile cover

  During blood sampling

Other Outcomes (4)

• Number of skin penetrations needed to puncture the vein

  During blood sampling

• Unexpected difficulties with the sterilization procedure

  during blood sampling

• Number of posterior vessel wall punctures

  during blood sampling

Study Arms (1)

modified commercial drape Tegaderm (R)

EXPERIMENTAL

Device: A product type of the modified commercial drape Tegaderm (R)

Interventions

A product type of the modified commercial drape Tegaderm (R) DEVICE

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.

Also known as: Drape: Tegaderm(R) Film (3M, USA).

modified commercial drape Tegaderm (R)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

RECRUITING

Study Officials

• Erik Sloth, Professor, MD

  Aarhus University Hospital

  STUDY DIRECTOR

Central Study Contacts

Sofie Thorn, student

CONTACT

0045 61711623; thorn@studmed.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research year student

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 7, 2013

Record last verified: 2013-02

Locations

DK (1)