TenTaTorch: Venepuncture Made Easy

NCT03202238 | Unknown

• 1 other identifier: 2018/01266
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of attempts

  Number of venepuncture attempts required for successful vein cannulation

  Up to 1 day from the point of venepuncture attempt

Secondary Outcomes (1)

• Duration of venepuncture

  Up to 1 day from the point of venepuncture attempt

Other Outcomes (1)

• Subjective user feedback

  Up to 1 day from the point of venepuncture attempt

Study Arms (3)

Conventional

ACTIVE COMPARATOR

Venepuncture without the use of any venepuncture assistive device

Other: Conventional

Veinlite

ACTIVE COMPARATOR

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

Device: Veinlite

TenTaTorch

EXPERIMENTAL

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

Device: TenTaTorch

Interventions

Conventional OTHER

Conventional venepuncture without use of any venepuncture assistive device.

Conventional

Veinlite DEVICE

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

Veinlite

TenTaTorch DEVICE

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

TenTaTorch

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with difficult venous access: Patients who have a history of 3 or more venepuncture attempts required for successful cannulation

You may not qualify if:

• Patients who require emergency blood sampling
• Patients who require emergency insertion of intra-venous cannula
• Patients who are haemodynamically unstable

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Elijah Cai, MBBS, MRCS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elijah Cai, MBBS, MRCS

CONTACT

97203639; elijah_cai@nuhs.edu.sg

Thiam Chye Lim, MD (Mal), FRCS, AM (Mal), FAMS

CONTACT

97599796; surlimtc@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2017
• First Posted: June 28, 2017
• Study Start: September 29, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 5, 2023
• Last Updated: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)