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

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ClinicalTrials.gov Identifier: NCT01785225
Recruitment Status : Unknown
Verified February 2013 by Sofie Thorn, Aarhus University Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Sofie Thorn, 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.


Condition or disease Intervention/treatment Phase
Ultrasound Sterile Puncture Area Blood Sampling Device: A product type of the modified commercial drape Tegaderm (R) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
Study Start Date : February 2013
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: modified commercial drape Tegaderm (R) Device: A 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.
Other Name: Drape: Tegaderm(R) Film (3M, USA).




Primary Outcome Measures :
  1. Number of successful blood withdrawals [ Time Frame: During blood sampling ]

Secondary Outcome Measures :
  1. Image quality with and without sterile cover [ Time Frame: During blood sampling ]

Other Outcome Measures:
  1. Number of skin penetrations needed to puncture the vein [ Time Frame: During blood sampling ]
  2. Unexpected difficulties with the sterilization procedure [ Time Frame: during blood sampling ]
    Does 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?

  3. Number of posterior vessel wall punctures [ Time Frame: during blood sampling ]
  4. Time spent from tourniquet is placed to blood withdrawals [ Time Frame: during blood sampling ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785225


Contacts
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Contact: Sofie Thorn, student 0045 61711623 thorn@studmed.au.dk

Locations
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Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus, Denmark, 8200
Contact: Sofie Thorn, Student    0045 61711623    thorn@studmed.au.dk   
Principal Investigator: Sofie Thorn, Student         
Sub-Investigator: Erik Sloth, Professor, MD         
Sponsors and Collaborators
Aarhus University Hospital
Danish Cancer Society
Investigators
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Study Director: Erik Sloth, Professor, MD Aarhus University Hospital

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Responsible Party: Sofie Thorn, Research year student, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01785225     History of Changes
Other Study ID Numbers: 1-10-72-589-12
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female