NCT03202238

TenTaTorch: Venepuncture Made Easy

Status unknown NA Last updated 28 October 2020

What this trial tests

NA trial testing Conventional in Vein Collapse in 120 participants. Status unknown.

Timeline

29 September 2019

Primary endpoint
1 October 2022

5 October 2023

Quick facts

Lead sponsor	National University Hospital, Singapore
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	device feasibility
Enrollment	120
Start date	29 September 2019
Primary completion	1 October 2022
Estimated completion	5 October 2023
Sites	1 location across Singapore

Drugs / interventions tested

• Conventional
• Veinlite
• TenTaTorch

Conditions studied

• Vein Collapse — all drugs for Vein Collapse →
• Vein Thrombosis — all drugs for Vein Thrombosis →
• Vein; Tortuous — all drugs for Vein; Tortuous →
• Vein Disease — all drugs for Vein Disease →

Sponsor

National University Hospital, Singapore

Who can join

Adults 21 to 100, any sex, with Vein Collapse or Vein Thrombosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.