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…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
For effective regional anesthesia and interventional pain treatments, correct
needle (and catheter) placement is crucial. Currently, needle placement is done
under image-guidance. However, accuracy of needle placement could still be
improved if information would be available that would complement the current
imaging and electrical stimulation methods. We have developed a system based on
optical spectroscopy that has the potential to provide such complementary
information.
This study will be an observational study in a limited number of volunteers to
investigate if the method can reliably discriminate vascular (venous) from
non-vascular punctures. Detection of vascular access is of particular relevance
to the fields of regional anesthesia and interventional pain.
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 defined: for one group the needle
endpoint will be in the subcutaneous fat of the anterior forearm, for the other
group, the needle endpoint will be inside a vein in the anterior forearm.
During the visit, a needle containing an optical stylet will be inserted
towards the needle endpoint, where data will be collected with the optical
tissue stylet system. The position of the needle tip at the endpoint will be
confirmed by ultrasound imaging and aspiration. After the measurements, the
needle and optical stylet will be withdrawn and disposed of.
Off-line,prediction of the needle endpoints based on the diffuse reflectance
spectra will be done by a blinded observer.
In case of positive results additional studies will be set up, for instance to
explore the potential of the optical tissue stylet technology to detect
epidural access, and accidental needle insertion into epidural veins. At a
later stage, one could envision studies investigating if providing the optical
tissue stylet data to the physician during a procedure results in improved
procedure success rates. For more detailed information, see pages 9 and 10 of
the corresponding protocol.
Study objective
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.
Study design
This is a single-blind randomized observational study
Study burden and risks
The procedure of inserting the needle and collecting the data will take about 5
minutes.
Subjects may experience some discomfort, similar to, or less than the
discomfort that subjects can experience during normal blood sample collection.
There is no direct benefit for the group of subjects; however, the results of
this investigation may in future assist the improvement of regional anesthesia
and interventional pain procedures. The volunteers will receive a small but
reasonable compensation for the potential discomfort.
High Tech Campus 34
5656 AE
NL
High Tech Campus 34
5656 AE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36528.091.11 |