Viewing Study NCT01785225



Ignite Creation Date: 2024-05-06 @ 1:19 AM
Last Modification Date: 2024-10-26 @ 11:02 AM
Study NCT ID: NCT01785225
Status: UNKNOWN
Last Update Posted: 2013-02-07
First Post: 2013-02-01

Brief Title: Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
Sponsor: Aarhus University Hospital
Organization: Aarhus University Hospital

Study Overview

Official Title: Ultrasound-guided Blood Sampling With a Sterile and Dry Puncture Area
Status: UNKNOWN
Status Verified Date: 2013-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 patients skin or blood A strict sterile procedure is important to reduce complications related to infectionThe 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: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None