Difficult Intravenous Access in Pediatrics Clinical Trial
— USgIVOfficial title:
A Randomized Control Trial of Ultrasound Guided IV Access in the Pediatric Emergency Department
NCT number | NCT02125552 |
Other study ID # | 13-010758 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | March 2017 |
Verified date | May 2018 |
Source | Children's Hospital of Philadelphia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective is to determine whether the use of ultrasound guidance compared to standard IV access improves the proportion of successful IV placement on a first attempt for children in a pediatric emergency department who have predicted difficult access by a validated score. Secondary objectives include determining whether ultrasound-guided IV access lowers the overall number of IV attempts and/or reduces time to IV access. The investigators will also examine the duration of IV access and any complications related to IV access in both the traditional and ultrasound guided IV access group.
Status | Completed |
Enrollment | 163 |
Est. completion date | March 2017 |
Est. primary completion date | December 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - Emergency department patients ages 0-18 years - Requiring IV access as determined by emergency department attending physician - Predicted difficult IV access as defined by a revised DIVA score >3 Exclusion Criteria: - Unstable patients triaged as a Level 1 triage acuity - Patients who refuse IV access - Non-English speaking parent/guardian - No study team member available to enroll patient - Parent/guardian does not consent - Allergy to ultrasound gel |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia |
United States,
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Dargin JM, Rebholz CM, Lowenstein RA, Mitchell PM, Feldman JA. Ultrasonography-guided peripheral intravenous catheter survival in ED patients with difficult access. Am J Emerg Med. 2010 Jan;28(1):1-7. doi: 10.1016/j.ajem.2008.09.001. — 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
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Gregg SC, Murthi SB, Sisley AC, Stein DM, Scalea TM. Ultrasound-guided peripheral intravenous access in the intensive care unit. J Crit Care. 2010 Sep;25(3):514-9. doi: 10.1016/j.jcrc.2009.09.003. Epub 2009 Oct 15. — View Citation
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success of Initial IV Placement Attempt | Patients will be randomized to traditional IV placement or ultrasound guided IV placement immediately after enrollment. The IV will be placed directly following enrollment. | Participants will be followed through the duration of emergency department stay, an expected average of 4 hours | |
Secondary | Measure the overall number of IV attempts.. | We will record the number of IV attempts made until a patient has a successfully placed IV or further attempts are aborted. | Participants will be followed through the duration of emergency department stay, an expected average of 4 hours | |
Secondary | Time to IV access. | The time from enrollment until successful IV access is obtained will be measured. | Participants will be followed through the duration of emergency department stay, an expected average of 4 hours | |
Secondary | Patient & family satisfaction with IV placement method. | A survey will be given to parents and patients over age 12 years to ask them about their experience with the IV placement. | Participants will be followed through the duration of emergency department stay, an expected average of 4 hours | |
Secondary | Compare the survival (in length of time) of IV access | We will track the IVs placed as part of the study through the electronic medical record to determine when and why they were removed and if there were any associated complications. | Participants will be followed through the duration of hospital stay, expected average of 5 days |