- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877301
Use of Ultrasound Guidance to Facilitate Obtaining Peripheral Intravenous Access
May 3, 2021 updated by: Children's Hospital Medical Center, Cincinnati
Use of Ultrasound Guidance to Facilitate Insertion of Peripheral Intravenous Catheter in Pediatric Patients
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ultrasound guidance
Ultrasound guidance used to facilitate insertion of PIV catheter.
|
Ultrasound guidance used to facilitate insertion of PIV catheter
|
ACTIVE_COMPARATOR: Non-ultrasound guidance
Ultrasound guidance will not be used for insertion of PIV catheter.
|
Ultrasound guidance will not be used for insertion of PIV catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of attempts to successful peripheral intravenous access cannulation.
Time Frame: 1 time - baseline visit
|
1 time - baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient pain score rating for PIV access attempt.
Time Frame: 1 time - baseline visit
|
1 time - baseline visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent satisfaction with child's PIV access experience.
Time Frame: 1 time - baseline visit
|
1 time - baseline visit
|
|
PIV extravasations.
Time Frame: 1 time - baseline visit
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sharon A Dwyer, ADN, Children's Hospital Medical Center, Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1542/peds.108.3.793.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2012
Primary Completion (ANTICIPATED)
December 1, 2014
Study Completion (ANTICIPATED)
December 1, 2014
Study Registration Dates
First Submitted
December 11, 2012
First Submitted That Met QC Criteria
May 3, 2021
First Posted (ACTUAL)
May 7, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 7, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- CIN001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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