AnesthesiaOTS-PSNCT01517386
Photonic Needle and Paravertebral Space Detection
An observational study of Anesthesia, run by Philips Healthcare at 1 site in Netherlands.
Trial summary
For effective anesthesia and interventional pain treatments, correct needle placement is crucial. Currently used methods to guide needle placement and confirm the actual treatment location before injection of the medication include: image-guidance, loss-of-resistance, and electrical stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- thoracic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia
Who may be able to join
- Elective unilateral thoracic surgery
- Age between 18 and 80 years of age
- Ability and willingness to provide informed consent
Who cannot join
- Pregnancy
- Photodynamic therapy
- Contraindications to regional anesthesia and/or allergy to amide local anesthetics.
- Subjects < 18 years of age or >80 years of age
- Severe coagulopathy
- Subjects with severe thoracic deformities
- Subjects with contraindications to methylene blue
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA
About this study
Official title: Optical Tissue Stylet (OTS) - Descriptive Observational Study Into Paravertebral Space (PS) Detection in Humans
For effective anesthesia and interventional pain treatments, correct needle placement is crucial. Currently used methods to guide needle placement and confirm the actual treatment location before injection of the medication include: image-guidance, loss-of-resistance, and electrical stimulation. However, accuracy of needle placement could be improved if information would be available that would complement the current methods. We have developed the so-called "photonic needle" technology based on optical spectroscopy that has the potential to provide such complementary information.
This study is an observational study in a limited number of patients. A common ultrasound-guided regional anesthesia procedure has been selected, during which data will be acquired with the photonic needles at a number of points along the needle trajectory that allow for confirmation by imaging.
Rationale for this study is to investigate the potential of the technology to discriminate tissues that are relevant to distinguish during the procedure.
Read the detailed description
The primary objective of the trial is to investigate if the photonic needle 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.
Main study parameters are:
- Successfully acquired diffuse reflectance spectra obtained in the thoracic paravertebral space, and spectra obtained during needle advancement.
- Confirmation of sonographic thoracic paravertebral localization, defined as tissue imaging in all locations of the needle where the diffuse reflectance spectra have been collected .
- Recordings of reaction to a small test dose of lidocaine 2% with epinephrine 1:200.000 at target position for regional anesthesia (to exclude vascular localization of the needle)
- "certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging and/or aspiration and/or reaction to a small injection of epinephrineOther study parameters
The endpoint of the study is a statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations.
- Conditions
- Anesthesia
- Being tested
- thoracic surgery
- Keywords
- paravertebral space, needle placement, tissue identification, regional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic surgeryProcedure or surgery
unilateral thoracic surgery under paravertebral block and general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| paravertebral anesthesia | patients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia Receives: Procedure: thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the thoracic paravertebral space
Statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Gert-Jan Scheffer, PhD, MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517386
- Sponsor's protocol ID
- NL37671.091.11
- Acronym
- OTS-PS
- Status last verified
- Jul 2012
- First submitted
- 20 Jan 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Tissue Stylet (OTS) - Descriptive Observational Study Into Paravertebral Space (PS) Detection in Humans
- ClinicalTrials.gov ID
- NCT01517386
- Acronym / sponsor ID
- OTS-PS / NL37671.091.11
- Conditions
- Anesthesia
- Keywords
- paravertebral space, needle placement, tissue identification, regional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Philips HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For effective anesthesia and interventional pain treatments, correct needle placement is crucial. Currently used methods to guide needle placement and confirm the actual treatment location before injection of the medication include: image-guidance, loss-of-resistance, and electrical stimulation. However, accuracy of needle placement could be improved if information would be available that would complement the current methods. We have developed the so-called "photonic needle" technology based on optical spectroscopy that has the potential to provide such complementary information.
This study is an observational study in a limited number of patients. A common ultrasound-guided regional anesthesia procedure has been selected, during which data will be acquired with the photonic needles at a number of points along the needle trajectory that allow for confirmation by imaging.
Rationale for this study is to investigate the potential of the technology to discriminate tissues that are relevant to distinguish during the procedure.
Detailed description
The primary objective of the trial is to investigate if the photonic needle 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.
Main study parameters are:
- Successfully acquired diffuse reflectance spectra obtained in the thoracic paravertebral space, and spectra obtained during needle advancement.
- Confirmation of sonographic thoracic paravertebral localization, defined as tissue imaging in all locations of the needle where the diffuse reflectance spectra have been collected .
- Recordings of reaction to a small test dose of lidocaine 2% with epinephrine 1:200.000 at target position for regional anesthesia (to exclude vascular localization of the needle)
- "certainty score" on a 3-point scale (1 = uncertain, 2 = certain, 3 = very certain) provided by the physician for assignment of the type of tissue present at the needle tip, based on the information available from imaging and/or aspiration and/or reaction to a small injection of epinephrineOther study parameters
The endpoint of the study is a statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paravertebral anesthesia | – | Procedure: thoracic surgerypatients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective unilateral thoracic surgery under paravertebral block and general anesthesia
Key inclusion criteria (3 listed)
- Elective unilateral thoracic surgery
- Age between 18 and 80 years of age
- Ability and willingness to provide informed consent
Key exclusion criteria (7 listed)
- Pregnancy
- Photodynamic therapy
- Contraindications to regional anesthesia and/or allergy to amide local anesthetics.
- Subjects < 18 years of age or >80 years of age
- Severe coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracic surgeryunilateral thoracic surgery under paravertebral block and general anesthesia | Procedure or surgery | paravertebral anesthesia |
Primary outcome
Identification of the thoracic paravertebral space
Time frame: Day 0
Statistical analysis of the difference between diffuse reflectance spectra obtained at non-paravertebral and paravertebral measurement locations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gert-Jan Scheffer, PhD, MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Philips Healthcare at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the thoracic paravertebral space (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.