TenTaTorch: Venepuncture Made Easy

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.

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.

Conditions

• Vein Collapse
• Vein Thrombosis
• Vein; Tortuous
• Vein Disease

Interventions

OTHER

Conventional

Conventional venepuncture without use of any venepuncture assistive device.

DEVICE

Veinlite

Commercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue

DEVICE

TenTaTorch

Transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue

Sponsors & Collaborators

• National University of Singapore

  collaborator OTHER

• National University Hospital, Singapore

  lead OTHER

Principal Investigators

• Elijah Cai, MBBS, MRCS · National University Hospital, Singapore

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-09-29

Primary Completion

2022-10-01

Completion

2023-10-05

Countries

• Singapore

Study Locations