Disorder of VeinNCT02570568
Pen Torch Transillumination: Shedding Light on Difficult Venepuncture
A study testing Veinlite, Pen-torch Transillumination and Conventional Venepuncture in people with Disorder of Vein, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Vein
- What is being tested?
- Veinlite, Pen-torch Transillumination and Conventional Venepuncture
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2015to Apr 2017
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a prospective randomized controlled trial. Patients with a history of difficult venepuncture who agree to be entered into the study will be randomized into one of 3 groups using a sealed envelope system: 1. Conventional venepuncture (Control Group, n=25); 2. Veinlite® a commercial LED transilluminator device (Experimental Group 1, n=25); 3. Pen torch transillumination (Experimental Group 2, n=25). Hemodynamically unstable patients are excluded. The nurse involved in the care of the patient will attempt venepuncture over the upper limb. A maximum of 4 times attempts is allowed, before escalation to a doctor/phlebotomist.
A standardized venepuncture technique using standardized instruments will be utilized. Veins will be localized using one of the above techniques. Pen torch transillumination and veinlite are non-invasive techniques for locating veins. For pen torch transillumination, the tip of the pen torch is pressed onto the skin, causing the shadow of the vein to show up. Veinlite uses a device that emits red light. Placing it 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.
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 attempt at venepuncture (refer to attached file). 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.
- Conditions
- Disorder of Vein
- Being tested
- Veinlite, Pen-torch Transillumination, Conventional Venepuncture
- Keywords
- Venepuncture, Transillumination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeinliteDevice
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.
Pen-torch TransilluminationDevice
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
Conventional VenepunctureProcedure or surgery
This involves the conventional method of identifying veins suitable for venepuncture, which involves visualization and palpation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Pen-torch Transillumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of venepuncture attempts
We record the number of attempts required for successful venepuncture
Measured: 1 day
Secondary outcomes (1)
Duration of venepuncture
A stopwatch will be used to measure the duration required from the start of vein identification, to the end of a successful venepuncture attempt.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disorder of VeinStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thiam Chye Lim, FRCS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570568
- Sponsor's protocol ID
- 2014/00152
- Other IDs
- 2014
- Status last verified
- Apr 2017
- First submitted
- 5 Oct 2015
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18277843Yen 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.
PubMed 23462399Mbamalu 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.
PubMed 10646021
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pen Torch Transillumination: Shedding Light on Difficult Venepuncture
- ClinicalTrials.gov ID
- NCT02570568
- Acronym / sponsor ID
- 2014/00152
- Conditions
- Disorder of Vein
- Keywords
- Venepuncture, Transillumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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.
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.
Detailed description
This is a prospective randomized controlled trial. Patients with a history of difficult venepuncture who agree to be entered into the study will be randomized into one of 3 groups using a sealed envelope system: 1. Conventional venepuncture (Control Group, n=25); 2. Veinlite® a commercial LED transilluminator device (Experimental Group 1, n=25); 3. Pen torch transillumination (Experimental Group 2, n=25). Hemodynamically unstable patients are excluded. The nurse involved in the care of the patient will attempt venepuncture over the upper limb. A maximum of 4 times attempts is allowed, before escalation to a doctor/phlebotomist.
A standardized venepuncture technique using standardized instruments will be utilized. Veins will be localized using one of the above techniques. Pen torch transillumination and veinlite are non-invasive techniques for locating veins. For pen torch transillumination, the tip of the pen torch is pressed onto the skin, causing the shadow of the vein to show up. Veinlite uses a device that emits red light. Placing it 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.
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 attempt at venepuncture (refer to attached file). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Venepuncture | Active comparator | Procedure: Conventional VenepunctureVeins 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. |
| Veinlite | Experimental | Device: VeinlitePlacing 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. |
| Pen-torch Transillumination | Experimental | Device: Pen-torch TransilluminationThe 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| VeinliteVeinlite 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. | Device | Veinlite |
| Pen-torch TransilluminationPen-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 | Device | Pen-torch Transillumination |
| Conventional VenepunctureThis involves the conventional method of identifying veins suitable for venepuncture, which involves visualization and palpation. | Procedure or surgery | Conventional Venepuncture |
Primary outcome
Number of venepuncture attempts
Time frame: 1 day
We record the number of attempts required for successful venepuncture
1 secondary outcome
Duration of venepuncture
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Results publication: PubMed 18277843Katsogridakis 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.
- Results publication: PubMed 23462399Yen 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.
- Results publication: PubMed 10646021Mbamalu 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.
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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.
Thiam Chye Lim, FRCS 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 Veinlite, Pen-torch Transillumination and Conventional Venepuncture in people with Disorder of Vein, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 14 Apr 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of venepuncture attempts (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570568, which also lists 3 linked publications.
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 14 Apr 2017.