Optical Tissue Stylet - study into vascular access in humans

ISRCTN ISRCTN15608308
DOI https://doi.org/10.1186/ISRCTN15608308
Secondary identifying numbers PhN-11035
Submission date
13/02/2015
Registration date
25/02/2015
Last edited
08/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Geert-Jan van Geffen
Scientific

Geert Grooteplein-Zuid 10
Nijmegen
6525 GA
Netherlands

Study information

Study designSingle-center single-blind randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific titleOptical Tissue Stylet - randomized controlled trial into vascular access in humans
Study objectivesThe 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(s)CMO regio Nijmegen-Arnhem (Committee on Research involving human subjects, area Nijmegen-Arnhem), registration number: 2011/198, NL number: NL365280.091.11
Health condition(s) or problem(s) studiedRegional anesthesia
InterventionVolunteers 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measureThe 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 measures1. 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 study start date01/01/2011
Completion date05/07/2011

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Total final enrolment20
Key inclusion criteria1. More than 18 years old
2. Healthy (category 1 of the ASA physical status classification system)
Key exclusion criteria1. Pregnancy
2. Photodynamic therapy
3. Inability to give informed consent
4. Category 2 and higher of the ASA physical status classification system
Date of first enrolment30/06/2011
Date of final enrolment05/07/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Anesthesiology Department, University Medical Centre Nijmegen (UMC St. Radboud)
Geert Grooteplein 10
Nijmegen
6525 GA
Netherlands

Sponsor information

Philips Healthcare
Industry

Veenpluis 4-6
Best
5684PC
Netherlands

ROR logo "ROR" https://ror.org/02p2bgp27

Funders

Funder type

Industry

Philips
Government organisation / For-profit companies (industry)
Alternative name(s)
Koninklijke Philips N.V., Royal Philips, Royal Philips N.V., Philips & Co
Location
Netherlands

Results and Publications

Intention to publish date30/03/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPublication is planned for Q2 of 2015
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol (other) 09/03/2017 08/03/2023 No No
Results article 09/03/2017 08/03/2023 Yes No

Editorial Notes

08/03/2023: Publication reference, protocol and total final enrolment added.