Regional anesthesia Not Applicable
Conditions
Interventions
Volunteers will be recruited via flyers and posters. The study will encompass one visit per subject. Subjects will be randomly divided into two groups. Per group, a different needle endpoint has been
Sponsors
Philips Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. More than 18 years old 2. Healthy (category 1 of the ASA physical status classification system)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 2. Recordings of positive/negative aspiration results for the locations where the diffuse reflectance spectra have been taken 3. Confirmation images by ultrasound, at the locations where the diffuse reflectance spectra have been collected 4. Estimates of the diameters of the punctured veins, based on information from ultrasound imaging 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 | — |
Countries
Netherlands
Outcome results
None listed