Plain English Summary
Background and study aims
Sometimes during an injection a blood vessel is accidently punctured. This unintended puncture may lead to serious complications. Spectral Tissue Sensing (STS) is a technique based on light, which can provide information about the tissue that is in front of the tip of the needle. Along with the image provided by ultrasound, this information might help to place the needle in the right position. To confirm this we would like to investigate this by placing a needle in the arm of healthy volunteers, in a vein or in fatty tissue.
Who can participate?
Healthy adult volunteers aged 18 or older.
What does the study involve?
You will be randomly allocated into one of two groups. The doctor will place a needle superficially into your arm. In one group the needle will be inserted into a vein and in the other group the needle will be inserted into fatty tissue. The doctor will use an ultrasound probe to guide the puncture. During the puncture optical data is collected. This takes about 20 seconds. During these 20 seconds, you will be asked to move as little as possible. The procedure of inserting the needle and collecting the data will take about 5 minutes.
What are the possible benefits and risks of participating?
There is no direct benefit for the group of subjects; however, the results of this study may in future assist the improvement of regional anesthesia and interventional pain procedures. We do not foresee any major risks in participating in this study. You may experience some discomfort, similar to or less than the discomfort that you would experience during normal blood sample collection. You will receive a small but reasonable compensation for the potential discomfort.
Where is the study run from?
University Medical Centre Nijmegen (Netherlands).
When is the study starting and how long is it expected to run for?
From June to July 2011.
Who is funding the study?
Philips Healthcare (Netherlands).
Who is the main contact?
Dr Geert-Jan van Geffen
University Medical Centre Radboud, Nijmegen
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PhN-11035
Study information
Scientific title
Optical Tissue Stylet - randomized controlled trial into vascular access in humans
Acronym
Study hypothesis
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.
Ethics approval
CMO regio Nijmegen-Arnhem (Committee on Research involving human subjects, area Nijmegen-Arnhem), registration number: 2011/198, NL number: NL365280.091.11
Study design
Single-center single-blind randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Regional anesthesia
Intervention
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.
Intervention type
Device
Phase
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/01/2011
Overall trial end date
05/07/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. More than 18 years old
2. Healthy (category 1 of the ASA physical status classification system)
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
30/06/2011
Recruitment end date
05/07/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
Anesthesiology Department, University Medical Centre Nijmegen (UMC St. Radboud)
Geert Grooteplein 10
Nijmegen
6525 GA
Netherlands
Funders
Funder type
Industry
Funder name
Philips
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Netherlands
Results and Publications
Publication and dissemination plan
Publication is planned for Q2 of 2015
Intention to publish date
30/03/2015
Participant level data
Available on request
Results - basic reporting
Publication summary