Vein CollapseNCT03202238
TenTaTorch: Venepuncture Made Easy
A study testing Conventional, Veinlite and TenTaTorch in people with Vein Collapse and Vein Thrombosis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Venepuncture can be challenging, especially in patients with co-morbidities that predispose them to have inaccessible veins. Multiple unsuccessful venepuncture attempts compromise patient care. It causes pain, delays in obtaining blood samples for investigations and instituting intra-venous treatment. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vein Collapse, Vein Thrombosis, Vein; Tortuous
- What is being tested?
- Conventional, Veinlite and TenTaTorch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Sep 2019to 5 Oct 2023
- Phase
- Interventional
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with difficult venous access: Patients who have a history of 3 or more venepuncture attempts required for successful cannulation
Who cannot join
- Patients who require emergency blood sampling
- Patients who require emergency insertion of intra-venous cannula
- Patients who are haemodynamically unstable
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Elijah Cai, MBBS, MRCS, 97203639, elijah_cai@nuhs.edu.sg
Thiam Chye Lim, MD, FRCS, AM, FAMS, 97599796, surlimtc@nus.edu.sg
About this study
Venepuncture can be challenging, especially in patients with co-morbidities that predispose them to have inaccessible veins. Multiple unsuccessful venepuncture attempts compromise patient care. It causes pain, delays in obtaining blood samples for investigations and instituting intra-venous treatment.
Venepuncture assistive devices (VAD) include ultrasonography, and devices that utilize infra-red or transillumination. These are expensive, not widely available, and have not been rigorously proven to be effective. We have previously performed a preliminary study using an ordinary pen-torch for transillumination showed promising results. 95% of patients with known difficult venous access required two or less attempts for successful cannulation. It costs 35 times cheaper compared to the cheapest VAD in the market. The concept is promising but the technique cumbersome.
Read more
Building upon the concept of transillumination, the aim of this study is to develop an idiot-proof cost-effective pocket-sized VAD (TenTaTorch) to improve venepuncture success. A randomized controlled trial (RCT) will be conducted to determine its safety and efficacy. The TenTaTorch prototype will be modelled using Computer-Aided Design (Inventor®, Autodesk®, California, USA) and fabricated using 3D-printing, with silicon casting. Compared to existing VADs, TenTaTorch consists of finger-mounted LED light sources that allows greater manoeuvrability during transillumination.
We include adult patients aged 21 to 100 with difficult venous access (history of ≥3 consecutive attempts required for successful cannulation during the current admission) requiring non-emergent venepuncture in the RCT. Each patient undergoes venepuncture over the upper-limb using one of the following: Conventional Venepuncture without aid (Control 1); Veinlite® EMS (TransLite®, Texas, USA) (Control 2), a commercial transillumination device; our device TenTaTorch (Experimental Group).
Outcome measures include: successful cannulation within 2 attempts; duration of venepuncture; subjective user feedback. Fisher's exact and Kruskal-Wallis tests will be performed.
Read the detailed description
This is a prospective randomized controlled trial. Patients with a history of difficult venepuncture who agreed to be enter into the study will be randomized into one of three groups using a sealed envelope system: Conventional Venepuncture without aid (Control 1); Veinlite® EMS (TransLite®, Texas, USA) (Control 2), a commercial transillumination device; our device TenTaTorch (Experimental Group). Hemodynamically unstable patients are excluded. The nurse involved in the care of the patient will attempt venepuncture over the upper limb. A group of nurses will be recruited before the start of patient recruitment. A maximum of 4 times attempts is allowed, before escalation to a doctor/phlebotomist.
A standardized venepuncture technique using standardized instruments will be utilized. A tourniquet is applied (Braun® International, USA). Veins will be localized using one of the above techniques. Both Veinlite and TenTaTorch utilize the concept of transillumination. Placing it onto the skin will cause the outlines of the veins to show up. Once a suitable vein is localized, the vein is marked with a pen. The area of the skin to be cannulated is disinfected with an alcohol wipe (Webcol®, Covidien®, USA). For the setting of IV cannulation, a standardized IV cannula (ranging 18 to 25 gauge) is used (Introcan Safety®, Braun®, USA). Normal saline (PosiFlush® 3ml, BD®, USA) will be used for flushing the cannula after successful cannulation. For blood taking, a syringe (Terumo®, Philippines) ranging from 2ml to 20ml and a needle (ranging between 18 to 25 gauge) (Venofix®, Braun®, USA) will be used. All instruments needed for venepuncture, including 4 IV cannula or 4 needles should be by the patient's bedside prior to the start of each venepuncture attempt. Duration of the procedure will be recorded using a stop watch. This is defined as the time (in minutes) from the start of attempt to localize a vein to its successful cannulation. Successful cannulation is defined either as the ability to flush 2ml of normal saline into the IV cannula or the ability to draw 2ml of blood from the vein. A post-procedure questionnaire will be filled up by the nurses after the attempt at venepuncture.
Outcome data include: number of attempts and duration needed for successful venepuncture. Patient data include: age, sex, race, body-mass index, history of intra-venous drug abuse, and renal function. Nurses who consent to join the study will be required to participate in a pre- trial tutorial which is estimated to last for 1 hour. During the tutorial, techniques of locating veins using TenTaTorch and by using the Veinlite® device will be taught. A standardized technique of venepuncture will also be taught. Tutorial will be in the form of slide- show presentation and hands-on training. During the hands-on training, nurses will attempt to identify veins on fellow trainees using both TenTaTorch and Veinlite®.
- Conditions
- Vein Collapse, Vein Thrombosis, Vein; Tortuous, Vein Disease
- Being tested
- Conventional, Veinlite, TenTaTorch
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConventionalOther
Conventional venepuncture without use of any venepuncture assistive device.
VeinliteDevice
Commercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue
TenTaTorchDevice
Transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Venepuncture without the use of any venepuncture assistive device Receives: Other: Conventional |
| Veinlite | Active comparator | Commercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue Receives: Device: Veinlite |
| TenTaTorch | Experimental | Transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue Receives: Device: TenTaTorch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts
Number of venepuncture attempts required for successful vein cannulation
Measured: Up to 1 day from the point of venepuncture attempt
Secondary outcomes (1)
Duration of venepuncture
Duration required for successful vein cannulation
Measured: Up to 1 day from the point of venepuncture attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start29 Sep 2019
- Primary completion1 Oct 2022 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vein CollapseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Elijah Cai, MBBS, MRCS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202238
- Sponsor's protocol ID
- 2018/01266
- Other IDs
- 2018
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2017
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TenTaTorch: Venepuncture Made Easy
- ClinicalTrials.gov ID
- NCT03202238
- Acronym / sponsor ID
- 2018/01266
- Conditions
- Vein Collapse, Vein Thrombosis, Vein; Tortuous, Vein Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
Venepuncture can be challenging, especially in patients with co-morbidities that predispose them to have inaccessible veins. Multiple unsuccessful venepuncture attempts compromise patient care. It causes pain, delays in obtaining blood samples for investigations and instituting intra-venous treatment.
Venepuncture assistive devices (VAD) include ultrasonography, and devices that utilize infra-red or transillumination. These are expensive, not widely available, and have not been rigorously proven to be effective. We have previously performed a preliminary study using an ordinary pen-torch for transillumination showed promising results. 95% of patients with known difficult venous access required two or less attempts for successful cannulation. It costs 35 times cheaper compared to the cheapest VAD in the market. The concept is promising but the technique cumbersome.
Building upon the concept of transillumination, the aim of this study is to develop an idiot-proof cost-effective pocket-sized VAD (TenTaTorch) to improve venepuncture success. A randomized controlled trial (RCT) will be conducted to determine its safety and efficacy. The TenTaTorch prototype will be modelled using Computer-Aided Design (Inventor®, Autodesk®, California, USA) and fabricated using 3D-printing, with silicon casting. Compared to existing VADs, TenTaTorch consists of finger-mounted LED light sources that allows greater manoeuvrability during transillumination.
We include adult patients aged 21 to 100 with difficult venous access (history of ≥3 consecutive attempts required for successful cannulation during the current admission) requiring non-emergent venepuncture in the RCT. Each patient undergoes venepuncture over the upper-limb using one of the following: Conventional Venepuncture without aid (Control 1); Veinlite® EMS (TransLite®, Texas, USA) (Control 2), a commercial transillumination device; our device TenTaTorch (Experimental Group).
Outcome measures include: successful cannulation within 2 attempts; duration of venepuncture; subjective user feedback. Fisher's exact and Kruskal-Wallis tests will be performed.
Detailed description
This is a prospective randomized controlled trial. Patients with a history of difficult venepuncture who agreed to be enter into the study will be randomized into one of three groups using a sealed envelope system: Conventional Venepuncture without aid (Control 1); Veinlite® EMS (TransLite®, Texas, USA) (Control 2), a commercial transillumination device; our device TenTaTorch (Experimental Group). Hemodynamically unstable patients are excluded. The nurse involved in the care of the patient will attempt venepuncture over the upper limb. A group of nurses will be recruited before the start of patient recruitment. A maximum of 4 times attempts is allowed, before escalation to a doctor/phlebotomist.
A standardized venepuncture technique using standardized instruments will be utilized. A tourniquet is applied (Braun® International, USA). Veins will be localized using one of the above techniques. Both Veinlite and TenTaTorch utilize the concept of transillumination. Placing it onto the skin will cause the outlines of the veins to show up. Once a suitable vein is localized, the vein is marked with a pen. The area of the skin to be cannulated is disinfected with an alcohol wipe (Webcol®, Covidien®, USA). For the setting of IV cannulation, a standardized IV cannula (ranging 18 to 25 gauge) is used (Introcan Safety®, Braun®, USA). Normal saline (PosiFlush® 3ml, BD®, USA) will be used for flushing the cannula after successful cannulation. For blood taking, a syringe (Terumo®, Philippines) ranging from 2ml to 20ml and a needle (ranging between 18 to 25 gauge) (Venofix®, Braun®, USA) will be used. All instruments needed for venepuncture, including 4 IV cannula or 4 needles should be by the patient's bedside prior to the start of each venepuncture attempt. Duration of the procedure will be recorded using a stop watch. This is defined as the time (in minutes) from the start of attempt to localize a vein to its successful cannulation. Successful cannulation is defined either as the ability to flush 2ml of normal saline into the IV cannula or the ability to draw 2ml of blood from the vein. A post-procedure questionnaire will be filled up by the nurses after the attempt at venepuncture.
Outcome data include: number of attempts and duration needed for successful venepuncture. Patient data include: age, sex, race, body-mass index, history of intra-venous drug abuse, and renal function. Nurses who consent to join the study will be required to participate in a pre- trial tutorial which is estimated to last for 1 hour. During the tutorial, techniques of locating veins using TenTaTorch and by using the Veinlite® device will be taught. A standardized technique of venepuncture will also be taught. Tutorial will be in the form of slide- show presentation and hands-on training. During the hands-on training, nurses will attempt to identify veins on fellow trainees using both TenTaTorch and Veinlite®.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Other: ConventionalVenepuncture without the use of any venepuncture assistive device |
| Veinlite | Active comparator | Device: VeinliteCommercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue |
| TenTaTorch | Experimental | Device: TenTaTorchTransilluminator device that allows veins to show up as a silhouette among surrounding soft tissue |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with difficult venous access: Patients who have a history of 3 or more venepuncture attempts required for successful cannulation
Key exclusion criteria (3 listed)
- Patients who require emergency blood sampling
- Patients who require emergency insertion of intra-venous cannula
- Patients who are haemodynamically unstable
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 |
|---|---|---|
| ConventionalConventional venepuncture without use of any venepuncture assistive device. | Other | Conventional |
| VeinliteCommercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue | Device | Veinlite |
| TenTaTorchTransilluminator device that allows veins to show up as a silhouette among surrounding soft tissue | Device | TenTaTorch |
Primary outcome
Number of attempts
Time frame: Up to 1 day from the point of venepuncture attempt
Number of venepuncture attempts required for successful vein cannulation
1 secondary outcome
Duration of venepuncture
Time frame: Up to 1 day from the point of venepuncture attempt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Elijah Cai, MBBS, MRCS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional, Veinlite and TenTaTorch in people with Vein Collapse and Vein Thrombosis, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2020. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elijah Cai, MBBS, MRCS (97203639, elijah_cai@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempts (time frame: Up to 1 day from the point of venepuncture attempt). 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 28 Oct 2020.