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Optical Tissue Stylet: Descriptive observational study into paravertebral space detection in humans.


- candidate number10930
- NTR NumberNTR3238
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2012
- Secondary IDsNL37671.091.11 / 2011/328; CCMO / CMO Regio Arnhem-Nijmegen
- Public TitleOptical Tissue Stylet: Descriptive observational study into paravertebral space detection in humans.
- Scientific TitleOptical Tissue Stylet: Descriptive observational study into paravertebral space detection in humans.
- ACRONYMOTS PS
- hypothesisThe primary objective of the trial is to investigate if the optical tissue stylet technology can reliably identify the thoracic paravertebral space. Diffuse reflectance spectra will be acquired during needle advancement, with custom-made needle stylets that contain optical fibers.
- Healt Condition(s) or Problem(s) studiedNeedle placement, Regional anesthesia, Paravertebral space
- Inclusion criteria1. Elective unilateral thoracic surgery;
2. Age between 18 and 80 years of age;
3. Male and female subjects;
4. Ability and willingness to provide informed consent.
- Exclusion criteria1. Pregnancy;
2. Photodynamic therapy;
3. Contraindications to regional anesthesia and/or allergy to amide local anesthetics;
4. Subjects < 18 years of age or >80 years of age;
5. Severe coagulopathy;
6. Subjects with severe thoracic deformities;
7. Subjects with contraindications to methylene blue.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 16-jan-2012
- planned closingdate31-mei-2012
- Target number of participants12
- InterventionsA stylet equipped with optical fibers is used to collect data during routine performance of paravertebral blocks for elective surgery. In addition, methylene blue will be injected to confirm paravertebral needle placement during surgery.
- Primary outcomeThis is an observational study. No outcome is measured.
- Secondary outcomeThis is an observational study. No outcome is measured.
- TimepointsMeasurements and observations take place during the procedure and subsequent surgery. No follow-up is required for this study.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Stefan Roggeveen
- CONTACT for SCIENTIFIC QUERIESDrs. I.J. Bruaset
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Anaesthesiology
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- PublicationsN/A
- Brief summaryThe primary objective of the trial is to investigate if the optical tissue stylet technology can reliably identify the thoracic paravertebral space. Diffuse reflectance spectra will be acquired during needle advancement, with custom-made needle stylets that contain optical fibers. The study takes place at the Radboud University Medical Centre in Nijmegen, The Netherlands. All patients are recruited in the Netherlands.
- Main changes (audit trail)
- RECORD13-jan-2012 - 1-dec-2012


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