PIV Catheter InsertionNCT01637987
Nurse PIV Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
A study testing Unassisted vein visualization, Wee Sight® Transilluminator and VeinViewer® (Christie Digital Systems, Cypress, CA) in people with PIV Catheter Insertion and Vein Visualization, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- PIV Catheter Insertion, Vein Visualization
- What is being tested?
- Unassisted vein visualization, Wee Sight® Transilluminator and VeinViewer® (Christie Digital Systems, Cypress, CA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2012to 2 Feb 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to Children's Hospital \& Medical Center Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/Intermediate Care Unit
- Require non-emergent PIV placement as part of medical plan of care
- Less than or equal to 12 month birth date
Who cannot join
- Greater than 12 month birth date
- PIV not required
- PIV inserted by practitioner other than RN
- PIV inserted by RN not employed by study areas
- Ward of state
- Require emergent PIV placement
- Primary language is not English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
About this study
Official title: Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods.
Read the detailed description
Obtaining peripheral intravenous (PIV) access is a nearly universal procedure for medical management of the hospitalized pediatric patient. In children, PIV placement can often be difficult due to the inability to identify peripheral veins (Wilson, 2007). Many assistive devices have been used or promoted to improve vein visualization with the intention of increasing PIV insertion success. Limited research was found to support this assumption regarding nursing PIV insertion success in children. This study is a randomized, controlled trial to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Patients admitted to Children's Hospital \& Medical Center (CHMC) Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/ Intermediate Care Unit, up to 12 months of age requiring non-emergent PIV placement as part of their medical plan of care will be eligible. Following consent subjects will be randomized into one of three vein identification method study groups (1) Wee Sight Transilluminator - a hand held light emitting device held adjacent to or under the patient's extremity to visualize the venous anatomy; (2) VeinViewer - uses near infrared light to view hemoglobin and projects an image of venous anatomy onto the skin; and (3) Unassisted Methods - traditional techniques of vein visualization and palpation. Based on study group assignment the nurse will use the appropriate vein identification method during the first two PIV insertion attempts. Evaluation of vein identification methods will be based on PIV insertion success or failure.
- Conditions
- PIV Catheter Insertion, Vein Visualization
- Being tested
- Unassisted vein visualization, Wee Sight® Transilluminator, VeinViewer® (Christie Digital Systems, Cypress, CA)
- Keywords
- Peripheral intravenous catheter, Vein visualization, Transillumination, Near infrared light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unassisted vein visualizationProcedure or surgery
Also called Traditional methods of vein identification
The traditional technique of vein visualization and palpation will be used to identify veins during the PIV insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification.
Wee Sight® TransilluminatorProcedure or surgery
Also called Vein Transillumination
The Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device is held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. Vein visualization improves with dimmed room lighting and a thin subcutaneous tissue layer. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the Wee Sight to assist in vein identification.
VeinViewer® (Christie Digital Systems, Cypress, CA)Procedure or surgery
Also called Vein Viewer
VeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein \& surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the VeinViewer to assist in vein identification.
| Study group | Role | What they receive |
|---|---|---|
| Unassisted vein visualization | Active comparator | The traditional technique of vein visualization and palpation will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification. Receives: Procedure: Unassisted vein visualization |
| Wee Sight Transilluminator | Active comparator | The Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device assists in vein identification by being held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. Receives: Procedure: Wee Sight® Transilluminator |
| Near Infra-red light (VeinViewer) | Active comparator | VeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein \& surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. Receives: Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful PIV insertion during first or second cannulation attempt.
Success = Insertion of a 22 or 24-gauge catheter into a peripheral vein followed by the immediate ability to flush 1-2 ml normal saline without signs of venous infiltration (e.g., pain and swelling).
Failure = Inability to insert a 22 or 24-gauge catheter into a peripheral vein, or insertion of a catheter into a peripheral vein followed by the immediate inability to flush 1-2 ml normal saline or signs of infiltration upon flushing.
Measured: Immediate upon completing first or second PIV insertion attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study start1 Jul 2012
- Primary completion2 Feb 2017
- Study completion2 Feb 2017
Why it stopped: Combination of insufficient research staff support, insufficient subjects meeting enrollment criteria, and investigators changing role responsibilities. Administratively closed (continuing review or completion report not submitted).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PIV Catheter InsertionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Responsible party
- Sponsor
- Investigators
- Kimberly A Peterson, MSN, Principal investigator, Children's Hospital and Medical Center, Omaha, NE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637987
- Sponsor's protocol ID
- 0694-11-EP
- Status last verified
- Dec 2023
- First submitted
- 6 Jul 2012
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peterson KA, Phillips AL, Truemper E, Agrawal S. Does the use of an assistive device by nurses impact peripheral intravenous catheter insertion success in children? J Pediatr Nurs. 2012 Apr;27(2):134-43. doi: 10.1016/j.pedn.2010.10.009. Epub 2011 Feb 18.
PubMed 22341192Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
PubMed 21854488Perry AM, Caviness AC, Hsu DC. Efficacy of a near-infrared light device in pediatric intravenous cannulation: a randomized controlled trial. Pediatr Emerg Care. 2011 Jan;27(1):5-10. doi: 10.1097/PEC.0b013e3182037caf.
PubMed 21178814Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.
PubMed 21067078
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
- ClinicalTrials.gov ID
- NCT01637987
- Acronym / sponsor ID
- 0694-11-EP
- Conditions
- PIV Catheter Insertion, Vein Visualization
- Keywords
- Peripheral intravenous catheter, Vein visualization, Transillumination, Near infrared light
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Combination of insufficient research staff support, insufficient subjects meeting enrollment criteria, and investigators changing role responsibilities. Administratively closed (continuing review or completion report not submitted).
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 2 Feb 2017 (actual)
- Study completion
- 2 Feb 2017 (actual)
- First posted
- 11 Jul 2012 (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.
The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods.
Detailed description
Obtaining peripheral intravenous (PIV) access is a nearly universal procedure for medical management of the hospitalized pediatric patient. In children, PIV placement can often be difficult due to the inability to identify peripheral veins (Wilson, 2007). Many assistive devices have been used or promoted to improve vein visualization with the intention of increasing PIV insertion success. Limited research was found to support this assumption regarding nursing PIV insertion success in children. This study is a randomized, controlled trial to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Patients admitted to Children's Hospital \& Medical Center (CHMC) Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/ Intermediate Care Unit, up to 12 months of age requiring non-emergent PIV placement as part of their medical plan of care will be eligible. Following consent subjects will be randomized into one of three vein identification method study groups (1) Wee Sight Transilluminator - a hand held light emitting device held adjacent to or under the patient's extremity to visualize the venous anatomy; (2) VeinViewer - uses near infrared light to view hemoglobin and projects an image of venous anatomy onto the skin; and (3) Unassisted Methods - traditional techniques of vein visualization and palpation. Based on study group assignment the nurse will use the appropriate vein identification method during the first two PIV insertion attempts. Evaluation of vein identification methods will be based on PIV insertion success or failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unassisted vein visualization | Active comparator | Procedure: Unassisted vein visualizationThe traditional technique of vein visualization and palpation will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification. |
| Wee Sight Transilluminator | Active comparator | Procedure: Wee Sight® TransilluminatorThe Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device assists in vein identification by being held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. |
| Near Infra-red light (VeinViewer) | Active comparator | Procedure: VeinViewer® (Christie Digital Systems, Cypress, CA)VeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein \& surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. This will be used to identify veins during peripheral intravenous line (PIV) insertion procedures. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admitted to Children's Hospital \& Medical Center Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/Intermediate Care Unit
- Require non-emergent PIV placement as part of medical plan of care
- Less than or equal to 12 month birth date
Key exclusion criteria (7 listed)
- Greater than 12 month birth date
- PIV not required
- PIV inserted by practitioner other than RN
- PIV inserted by RN not employed by study areas
- Ward of 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 |
|---|---|---|
| Unassisted vein visualizationAlso: Traditional methods of vein identificationThe traditional technique of vein visualization and palpation will be used to identify veins during the PIV insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification. | Procedure or surgery | Unassisted vein visualization |
| Wee Sight® TransilluminatorAlso: Vein TransilluminationThe Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device is held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. Vein visualization improves with dimmed room lighting and a thin subcutaneous tissue layer. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the Wee Sight to assist in vein identification. | Procedure or surgery | Wee Sight Transilluminator |
| VeinViewer® (Christie Digital Systems, Cypress, CA)Also: Vein ViewerVeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein \& surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the VeinViewer to assist in vein identification. | Procedure or surgery | Near Infra-red light (VeinViewer) |
Primary outcome
Successful PIV insertion during first or second cannulation attempt.
Time frame: Immediate upon completing first or second PIV insertion attempt
Success = Insertion of a 22 or 24-gauge catheter into a peripheral vein followed by the immediate ability to flush 1-2 ml normal saline without signs of venous infiltration (e.g., pain and swelling). Failure = Inability to insert a 22 or 24-gauge catheter into a peripheral vein, or insertion of a catheter into a peripheral vein followed by the immediate inability to flush 1-2 ml normal saline or signs of infiltration upon flushing.
Results and safety
The study was stopped early (reason given: Combination of insufficient research staff support, insufficient subjects meeting enrollment criteria, and investigators changing role responsibilities. Administratively closed (continuing review or completion report not submitted).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 22341192Peterson KA, Phillips AL, Truemper E, Agrawal S. Does the use of an assistive device by nurses impact peripheral intravenous catheter insertion success in children? J Pediatr Nurs. 2012 Apr;27(2):134-43. doi: 10.1016/j.pedn.2010.10.009. Epub 2011 Feb 18.
- Background: PubMed 21854488Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.
- Background: PubMed 21178814Perry AM, Caviness AC, Hsu DC. Efficacy of a near-infrared light device in pediatric intravenous cannulation: a randomized controlled trial. Pediatr Emerg Care. 2011 Jan;27(1):5-10. doi: 10.1097/PEC.0b013e3182037caf.
- Background: PubMed 21067078Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.
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.
Kimberly A Peterson, MSN principal investigator
Children's Hospital and Medical Center, Omaha, NE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unassisted vein visualization, Wee Sight® Transilluminator and VeinViewer® (Christie Digital Systems, Cypress, CA) in people with PIV Catheter Insertion and Vein Visualization, run by University of Nebraska at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 3 Jan 2024. 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 United States. 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 was stopped early (reason given: Combination of insufficient research staff support, insufficient subjects meeting enrollment criteria, and investigators changing role responsibilities. Administratively closed (continuing review or completion report not submitted).). Results are not available in the source record.
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?
Successful PIV insertion during first or second cannulation attempt. (time frame: Immediate upon completing first or second PIV insertion attempt). 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 NCT01637987, which also lists 4 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 3 Jan 2024.