Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access

NCT04877301 | Withdrawn DMC

• 1 other identifier: CIN001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

• Number of attempts to successful peripheral intravenous access cannulation.

  1 time - baseline visit

Secondary Outcomes (1)

• Patient pain score rating for PIV access attempt.

  1 time - baseline visit

Other Outcomes (2)

• Parent satisfaction with child's PIV access experience.

  1 time - baseline visit

• PIV extravasations.

  1 time - baseline visit

Study Arms (2)

Ultrasound guidance

EXPERIMENTAL

Ultrasound guidance used to facilitate insertion of PIV catheter.

Device: Ultrasound guidance

Non-ultrasound guidance

ACTIVE COMPARATOR

Ultrasound guidance will not be used for insertion of PIV catheter.

Procedure: Non-ultrasound guidance

Interventions

Ultrasound guidance DEVICE

Ultrasound guidance used to facilitate insertion of PIV catheter

Ultrasound guidance

Non-ultrasound guidance PROCEDURE

Ultrasound guidance will not be used for insertion of PIV catheter

Non-ultrasound guidance

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (10)

• 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.

  BACKGROUND

• 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.

  PMID: 19561750 BACKGROUND

• 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.

  PMID: 23271150 BACKGROUND

• 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.

  PMID: 16271677 BACKGROUND

• 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.

  PMID: 19262420 BACKGROUND

• 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.

  PMID: 9838 BACKGROUND

• 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.

  PMID: 19748021 BACKGROUND

• 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.

  PMID: 15194622 BACKGROUND

• Walsh, G. (2008). Difficult peripheral venous access: recognizing and managing the patient at risk. Journal of the Association for Vascular Access, 13, 198-203.

  BACKGROUND

• 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.

  PMID: 18347490 BACKGROUND

Study Officials

• Sharon A Dwyer, ADN

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Neil Johnson, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: May 7, 2021
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 7, 2021

Record last verified: 2013-08

Locations

US (1)