Optical tissue stylet - observational study into vascular access in humans

Optical tissue stylet - observational study into vascular access in humans - OTS VA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35810

Enrollment

Registered

2011-06-29

Start date

2011-06-30

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intravascular needle placement

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: category 1 of the ASA physical status classification system ("healthy")

Exclusion criteria

Exclusion criteria: Subjects who undergo photodynamic therapy, subjects

Design outcomes

Primary

Measure	Time frame
Main study parameters are: 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.	—

Measure

Time frame

Main study parameters are: 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