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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04877301
Other study ID # CIN001
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2012
Est. completion date December 2014

Study information

Verified date August 2013
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound guidance
Ultrasound guidance used to facilitate insertion of PIV catheter
Procedure:
Non-ultrasound guidance
Ultrasound guidance will not be used for insertion of PIV catheter

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (10)

American Academy of Pediatrics. Committee on Psychosocial Aspects of Child and Family Health; Task Force on Pain in Infants, Children, and Adolescents. The assessment and management of acute pain in infants, children, and adolescents. Pediatrics. 2001 Sep;108(3):793-7. — View 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. — View 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. — View 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. — View 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. — View Citation

Johnstone M. The effect of lorazepam on the vasoconstriction of fear. Anaesthesia. 1976 Sep;31(7):868-72. — View 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. Review. — View 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. Epub 2004 Jun 11. — View 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.

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Parent satisfaction with child's PIV access experience. 1 time - baseline visit
Other PIV extravasations. Cincinnati Children's Hospital has an initiative to reduce the number of PIV extravasations. The investigators will measure the number of extravasations in the study participants to determine if ultrasound guidance has an effect on this number. 1 time - baseline visit
Primary Number of attempts to successful peripheral intravenous access cannulation. 1 time - baseline visit
Secondary Patient pain score rating for PIV access attempt. 1 time - baseline visit
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