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

NCT ID: NCT01785225

Last Updated: 2013-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Ultrasound Sterile Puncture Area Blood Sampling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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modified commercial drape Tegaderm (R)

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Cancer Society

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sofie Thorn

Research year student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Sloth, Professor, MD

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

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Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sofie Thorn, student

Role: CONTACT

0045 61711623

Facility Contacts

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Sofie Thorn, Student

Role: primary

0045 61711623

Other Identifiers

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1-10-72-589-12

Identifier Type: -

Identifier Source: org_study_id

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