Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02618252
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2015-11-04
Brief Title:
Ultrasound vs Veinviewer in Patients With Difficulty IV Access
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Preventing Delay of Care in Patient With Difficult IV Access A Randomized Trial of ED Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with difficulty intravenous access frequently have delay of care in emergency departments because Emergency Department ED personnel could not establish intravenous IV access for diagnostic blood test or treatment The ultrasound machine or near-infrared devices have been used to improve this situation but no study has ever compared which machine is more efficient This study is designed to investigate whether the ultrasound or Vein Viewer which is a near-infrared device is more efficient
Detailed Description:
Intravenous IV access is important for patient care in emergency medicine as an estimate of 78 of ED patients would require more than 3 ED resources such as blood tests medication contrast fluid Care for patients with difficult intravenous access DIVA could be significantly delayed as it may take up to 120 minutes to establish IV access in patients with severe DIVA Many solutions for DIVA had also been established to avoid central venous catheter insertion including using ultrasound or near-infrared imaging systems for peripheral IV insertion
Using ultrasound in the ED has been shown to decrease the rate of central venous catheters CVC insertion However the results from ultrasound-guided peripheral IV insertion USGPIV have been mixed Among patients with DIVA Costantino reported USGPIV required less time to successful first cannulation and fewer punctures comparing to traditional approach of landmark and palpation However other studies showed that USGPIV did not improve successful first attempts comparing to traditional IV insertion and may have taken same or even longer time to successfully establish IV USGPIV success rate requires more training for nurses and ED technicians as it is operator - dependent
Patients have difficulty with IV access because their veins clinical accessibility is low for example they are less visible or less palpable The near-infrared imaging devices such as Christie Digitals VeinViewer improve this situation by using infra-red lights to make veins visible to the eyes
Compared with routine IV insertion near-Infra red imaging devices have been shown to increase first successful attempts and in less time in children with DIVA and improved visualization of peripheral veins However it did not show higher rate of successful attempts nor faster time in non-selected adults
The efficacy of these near-infrared devices has not been established among adult patients with DIVA
Using ultrasound in the ED has been shown to decrease the rate of central venous catheters CVC insertion However the results from ultrasound-guided peripheral IV insertion USGPIV have been mixed Among patients with DIVA Costantino reported USGPIV required less time to successful first cannulation and fewer punctures comparing to traditional approach of landmark and palpation However other studies showed that USGPIV did not improve successful first attempts comparing to traditional IV insertion and may have taken same or even longer time to successfully establish IV USGPIV success rate requires more training for nurses and ED technicians as it is operator - dependent
Patients have difficulty with IV access because their veins clinical accessibility is low for example they are less visible or less palpable The near-infrared imaging devices such as Christie Digitals VeinViewer improve this situation by using infra-red lights to make veins visible to the eyes
Compared with routine IV insertion near-Infra red imaging devices have been shown to increase first successful attempts and in less time in children with DIVA and improved visualization of peripheral veins However it did not show higher rate of successful attempts nor faster time in non-selected adults
The efficacy of these near-infrared devices has not been established among adult patients with DIVA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None