Clinical trial NCT04877301: Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access
Official title: Use of Ultrasound Guidance to Facilitate Insertion of Peripheral Intravenous Catheter in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Catheterization, Peripheral
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the use of ultrasound guidance to insert peripheral intravenous catheters will decrease the number of punctures required to successful insertion. The hypothesis is that fewer attempts will be required with the use of ultrasound potentially leading to preservation of vessels, decreased patient pain scores and increased patient/parent satisfaction.

Detailed description: Patients with known or current difficult venous access will be referred to the Vascular Access Team for peripheral intravenous catheter insertion. The Vascular Access Team will randomize patients to ultrasound guidance or non-ultrasound guidance for placement of the peripheral intravenous catheter.

Eligibility criteria: Inclusion Criteria:

* patients 0-17 years of age requiring peripheral intravenous access
* have not had PIV attempt in preceding 24 hours

Exclusion Criteria:

* patients who are medically unstable
* patients who require emergent intravenous access

Primary outcomes:
measure: Number of attempts to successful peripheral intravenous access cannulation.
timeFrame: 1 time - baseline visit
Secondary outcomes:
measure: Patient pain score rating for PIV access attempt.
timeFrame: 1 time - baseline visit
Other outcomes:
measure: Parent satisfaction with child's PIV access experience.
timeFrame: 1 time - baseline visit
measure: PIV extravasations.
timeFrame: 1 time - baseline visit
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Sharon A Dwyer, ADN
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Neil Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Academy of Pediatrics Committee on Psychosocial Aspects of Child and Family Health, American Pain Society, Task Force on Pain in Infants, Children, and Adolescents (2001). The assessment and management of acute pain in infants, children, and adolescents. American Academy of Pediatrics, 108, 793-797.
citation: Bair AE, Rose JS, Vance CW, Andrada-Brown E, Kuppermann N. Ultrasound-assisted peripheral venous access in young children: a randomized controlled trial and pilot feasibility study. West J Emerg Med. 2008 Nov;9(4):219-24.
citation: Clark E, Giambra BK, Hingl J, Doellman D, Tofani B, Johnson N. Reducing risk of harm from extravasation: a 3-tiered evidence-based list of pediatric peripheral intravenous infusates. J Infus Nurs. 2013 Jan-Feb;36(1):37-45. doi: 10.1097/NAN.0b013e3182798844.
citation: Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.
citation: Doniger SJ, Ishimine P, Fox JC, Kanegaye JT. Randomized controlled trial of ultrasound-guided peripheral intravenous catheter placement versus traditional techniques in difficult-access pediatric patients. Pediatr Emerg Care. 2009 Mar;25(3):154-9. doi: 10.1097/PEC.0b013e31819a8946.
citation: Johnstone M. The effect of lorazepam on the vasoconstriction of fear. Anaesthesia. 1976 Sep;31(7):868-72. doi: 10.1111/j.1365-2044.1976.tb11897.x.
citation: Kuensting LL, DeBoer S, Holleran R, Shultz BL, Steinmann RA, Venella J. Difficult venous access in children: taking control. J Emerg Nurs. 2009 Sep;35(5):419-24. doi: 10.1016/j.jen.2009.01.014. Epub 2009 Mar 21. No abstract available.
citation: Sandhu NP, Sidhu DS. Mid-arm approach to basilic and cephalic vein cannulation using ultrasound guidance. Br J Anaesth. 2004 Aug;93(2):292-4. doi: 10.1093/bja/aeh179. Epub 2004 Jun 11.
citation: Walsh, G. (2008). Difficult peripheral venous access: recognizing and managing the patient at risk. Journal of the Association for Vascular Access, 13, 198-203.
citation: Yen K, Riegert A, Gorelick MH. Derivation of the DIVA score: a clinical prediction rule for the identification of children with difficult intravenous access. Pediatr Emerg Care. 2008 Mar;24(3):143-7. doi: 10.1097/PEC.0b013e3181666f32.