Optical Tissue Stylet - study into vascular access in humans
Not Applicable
Completed
- Conditions
- Regional anesthesiaNot Applicable
- Registration Number
- ISRCTN15608308
- Lead Sponsor
- Philips Healthcare
- Brief Summary
2017 Results article in https://pubmed.ncbi.nlm.nih.gov/28278194/ (added 08/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. More than 18 years old
2. Healthy (category 1 of the ASA physical status classification system)
Exclusion Criteria
1. Pregnancy
2. Photodynamic therapy
3. Inability to give informed consent
4. Category 2 and higher of the ASA physical status classification system
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the trial is to investigate if the optical tissue stylet technology can reliably discriminate intra-vascular (venous) from non-vascular punctures. Diffuse reflectance spectra will be acquired for these two situations, with custom-made needle stylets that contain optical fibers.
- Secondary Outcome Measures
Name Time Method <br> 1. Successfully acquired diffuse reflectance spectra obtained in subcutaneous fat surrounding the veins in the anterior forearm, and spectra obtained with the needle tip inside veins in the anterior forearm<br> 2. Recordings of positive/negative aspiration results for the locations where the diffuse reflectance spectra have been taken<br> 3. Confirmation images by ultrasound, at the locations where the diffuse reflectance spectra have been collected<br> 4. Estimates of the diameters of the punctured veins, based on information from ultrasound imaging<br> 5. Percentages correctly identified positive and negative vessel punctures, where the identification is provided by an observer who only has access to the diffuse reflectance spectra, and is blinded to all other aspects of the procedures<br>