Optical tissue stylet - observational study into vascular access in humans
Recruiting
- Conditions
- intravascular needle placement10009720
- Registration Number
- NL-OMON35810
- Lead Sponsor
- Philips
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
category 1 of the ASA physical status classification system (healthy)
Exclusion Criteria
Subjects who undergo photodynamic therapy, subjects < 18 years of age, pregnant subjects, and subjects who have coagulation deficiencies will be excluded from participation
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters are:<br /><br>1. Successfully acquired diffuse reflectance spectra obtained in subcutaneous<br /><br>fat surrounding the veins in the anterior forearm, and spectra obtained with<br /><br>the needle tip inside veins in the anterior forearm.<br /><br>2. Recordings of positive/negative aspiration results for the locations where<br /><br>the diffuse reflectance spectra have been taken.<br /><br>3. Confirmation images by ultrasound, at the locations where the diffuse<br /><br>reflectance spectra have been collected.<br /><br>4. Estimates of the diameters of the punctured veins, based on information from<br /><br>ultrasound imaging.<br /><br>5. Percentages correctly identified positive and negative vessel punctures,<br /><br>where the identification is provided by an observer who only has access to the<br /><br>diffuse reflectance spectra, and is blinded to all other aspects of the<br /><br>procedures. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>