Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access

NCT ID: NCT04877301

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Catheterization, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ultrasound guidance

Ultrasound guidance used to facilitate insertion of PIV catheter.

Group Type EXPERIMENTAL

Ultrasound guidance

Intervention Type DEVICE

Ultrasound guidance used to facilitate insertion of PIV catheter

Non-ultrasound guidance

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

Group Type ACTIVE_COMPARATOR

Non-ultrasound guidance

Intervention Type PROCEDURE

Ultrasound guidance will not be used for insertion of PIV catheter

Interventions

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Ultrasound guidance

Ultrasound guidance used to facilitate insertion of PIV catheter

Intervention Type DEVICE

Non-ultrasound guidance

Ultrasound guidance will not be used for insertion of PIV catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon A Dwyer, ADN

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Neil Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 19561750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23271150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16271677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19262420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19748021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15194622 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 18347490 (View on PubMed)

Other Identifiers

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CIN001

Identifier Type: -

Identifier Source: org_study_id

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