Clinical trial NCT01637987: Nurse PIV Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
Official title: Nurse Peripheral Intravenous Catheter Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PIV Catheter Insertion
Vein Visualization
Keywords: Peripheral intravenous catheter
Vein visualization
Transillumination
Near infrared light
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Medical Center, Omaha, Nebraska
First posted: 2012-07-11
Enrollment: 104
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Successful PIV insertion during first or second cannulation attempt.
timeFrame: Immediate upon completing first or second PIV insertion attempt
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Children's Hospital and Medical Center
state: Nebraska
Study officials:
affiliation: Children's Hospital and Medical Center, Omaha, NE
name: Kimberly A Peterson, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Chapman 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.
citation: Perry 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.
citation: Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.