Pen Torch Transillumination: Shedding Light on Difficult Venepuncture

NCT02570568 | Completed DMC

• 1 other identifier: 2014/00152
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Our novel technique of pen-torch transillumination (PTI) uses a cheap and easily available instrument (Penlite-LP212®, Energizer®, Missouri, USA) to visualize superficial veins invisible to the naked eye. The investigators evaluate the efficacy of PTI in improving venepuncture success rate (SR) for patients with poor venous access. This prospective randomized controlled trial looks at adult patients aged 21 to 90 with difficult venous access (history of ≥3 consecutive attempts required for successful cannulation during the current admission) requiring non-emergent venepuncture. Patients will undergo venepuncture over the upper-limb using one of the following: Conventional venepuncture (control); Veinlite® (TransLite®, Texas, USA), a commercial transillumination device; PTI. Outcome measures are: successful cannulation within 2 attempts; duration of each successful attempt. Fisher's exact and Kruskal-Wallis tests will be performed.

Conditions

Disorder of Vein

Keywords

Venepuncture; Transillumination

Outcome Measures

Primary Outcomes (1)

• Number of venepuncture attempts

  We record the number of attempts required for successful venepuncture

  1 day

Secondary Outcomes (1)

• Duration of venepuncture

  1 day

Study Arms (3)

Conventional Venepuncture

ACTIVE COMPARATOR

Veins will be identified by a combination of visualization and palpation. Once a suitable vein is localized, a tourniquet is applied (Braun® International, USA). 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 23G IV cannula 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 23G needle (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.

Procedure: Conventional Venepuncture

Veinlite

EXPERIMENTAL

Placing Veinlite onto the skin will cause the outlines of the veins to show up. Once a suitable vein is localized, a tourniquet is applied (Braun® International, USA). 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 23G IV cannula 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 23G needle (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.

Device: Veinlite

Pen-torch Transillumination

EXPERIMENTAL

The tips of the pen torches are pressed onto the skin, causing the silhouette of the vein to show up. Once a suitable vein is localized, a tourniquet is applied (Braun® International, USA). 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 23G IV cannula 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 23G needle (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.

Device: Pen-torch Transillumination

Interventions

Veinlite DEVICE

Veinlite is a device that emits red light. It provides a non-invasive technique of inserting intra-venous cannula. Placing it onto the skin will cause the outlines of the veins to show up.

Veinlite

Pen-torch Transillumination DEVICE

Pen-torch Transillumination is a non-invasive technique that utilizes 2 pen-torches to provide illumination.The tips of the pen torches are pressed onto the skin, causing the silhouette of the vein to show up

Pen-torch Transillumination

Conventional Venepuncture PROCEDURE

This involves the conventional method of identifying veins suitable for venepuncture, which involves visualization and palpation.

Conventional Venepuncture

Eligibility Criteria

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

You may qualify if:

• History of ≥3 consecutive attempts required for successful cannulation during the current admission
• Patients requiring non-emergent venous cannulation for blood sampling or intra-venous plug insertion

You may not qualify if:

• Patients who are haemodynamically unstable
• Respiratory Rate (\< 8 or \> 30 / min) SpO2 (\< 93% on max 4L O2 on NP) Pulse rate (\< 40 or \> 130 bpm) Blood pressure (SBP \< 90 mmHg) Acute change in mental state

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

Related Publications (3)

• Katsogridakis YL, Seshadri R, Sullivan C, Waltzman ML. Veinlite transillumination in the pediatric emergency department: a therapeutic interventional trial. Pediatr Emerg Care. 2008 Feb;24(2):83-8. doi: 10.1097/PEC.0b013e318163db5f.

  PMID: 18277843 RESULT

• Yen K, Gorelick MH. New biomedical devices that use near-infrared technology to assist with phlebotomy and vascular access. Pediatr Emerg Care. 2013 Mar;29(3):383-5; quiz 386-7. doi: 10.1097/PEC.0b013e31828680f9.

  PMID: 23462399 RESULT

• Mbamalu D, Banerjee A. Methods of obtaining peripheral venous access in difficult situations. Postgrad Med J. 1999 Aug;75(886):459-62. doi: 10.1136/pgmj.75.886.459.

  PMID: 10646021 RESULT

Study Officials

• Thiam Chye Lim, FRCS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

SG (1)