Baltimore, Maryland 21201


Purpose:

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.


Study summary:

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 Digital's 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.


Criteria:

Inclusion Criteria: - Patients who fail inspections for visible or palpable veins or - Patients who request Ultrasound guided peripheral IV (USGPIV) - patients who are oriented to self (correct last name, first name), place (correct name of hospital), time (correct day of week or month of year) and person (correct name of current president) Exclusion Criteria: - Patients < 18 years of age - Patients with hemodynamically instability requiring rapid central access. - Patients with impaired cognition and not able to consent, these patients are : - Clinically intoxicated patients, as defined by primary team. - Patients who family reported as "confused", "confusion", "altered mental status." - Patients who is not oriented x 4 as above - Patients who do not speak English.


Study is Available At:


Original ID:

HP-00065438


NCT ID:

NCT02618252


Secondary ID:


Study Acronym:


Brief Title:

Ultrasound vs Veinviewer in Patients With Difficulty IV Access


Official Title:

Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Maryland, Baltimore


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

216


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Quincy Tran, MD, PhD
Principal Investigator
University of Maryland, College Park
Primary Contact:Quincy Tran, MD PhD
410-328-4143
qtran@som.umaryland.edu
Backup Contact:Robert Brown, MD
rmb440@gmail.com

Study Dates

Start Date:August 2016
Completion Date:July 2020
Completion Type:Anticipated
Primary Completion Date:July 2020
Primary Completion Type:Anticipated
Verification Date:February 2019
Last Changed Date:February 4, 2019
First Received Date:November 4, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of failure to cannulate
Time Frame:40 minutes
Safety Issues:False
Description:operators have up to 40 minutes or 3 attempts.
Outcome Type:Secondary Outcome
Measure:Cannulation time
Time Frame:40 minutes
Safety Issues:False
Description:time from applying tourniquet to successful aspiration of 3ml of blood.
Outcome Type:Secondary Outcome
Measure:hospital length of stay for admitted patient
Time Frame:30 days
Safety Issues:False
Description:Length of stay for admitted patients
Outcome Type:Secondary Outcome
Measure:ED length of stay
Time Frame:24 hours
Safety Issues:False
Description:Length of stay for discharged patients.
Outcome Type:Secondary Outcome
Measure:Patient's perception of pain
Time Frame:up to 40 minutes
Safety Issues:False
Description:after completion of IV cannulation
Outcome Type:Secondary Outcome
Measure:Patient satisfaction
Time Frame:up to 40 minutes
Safety Issues:False
Description:after completion of IV cannulation
Outcome Type:Secondary Outcome
Measure:IV size
Time Frame:40 minutes
Safety Issues:False
Description:operators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge
Outcome Type:Secondary Outcome
Measure:Number of failures
Time Frame:40 minutes
Safety Issues:False
Description:operators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality
Outcome Type:Secondary Outcome
Measure:Number of first successful attempts
Time Frame:40 minutes
Safety Issues:False
Description:operators have up to 40 minutes or 3 attempts.
Outcome Type:Primary Outcome
Measure:Operator's time
Time Frame:up to 40 minutes
Safety Issues:False
Description:time from equipment-in-room to successful aspiration of 3ml of blood

Study Interventions

Intervention Type:Device
Name:Zonare
Description:Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
Arm Name:Zonare
Intervention Type:Device
Name:Veinviewer
Description:Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
Arm Name:Veinviewer

Study Arms

Study Arm Type:Experimental
Arm Name:Zonare
Description:108 patients are randomized to receive the intervention of using ultrasound machine (Zonare ZS3 machine) for IV cannulation. These patients will first undergo IV cannulation with assistance of the ultrasound machine.
Study Arm Type:Experimental
Arm Name:Veinviewer
Description:108 Patients are randomized to receive the Intervention of using the Veinviewer Flex machine for IV cannulation. These patients will first undergo IV cannulation with assistance of the Veinviewer Flex machine.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Maryland, College Park

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Tanabe P, Gimbel R, Yarnold PR, Adams JG. The Emergency Severity Index (version 3) 5-level triage system scores predict ED resource consumption. J Emerg Nurs. 2004 Feb;30(1):22-9.
PMID:14765078
Reference Type:Reference
Citation:Witting MD. IV access difficulty: incidence and delays in an urban emergency department. J Emerg Med. 2012 Apr;42(4):483-7. doi: 10.1016/j.jemermed.2011.07.030. Epub 2011 Dec 2.
PMID:22137793
Reference Type:Reference
Citation:Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
PMID:19371518
Reference Type:Reference
Citation:Maiocco G, Coole C. Use of ultrasound guidance for peripheral intravenous placement in difficult-to-access patients: advancing practice with evidence. J Nurs Care Qual. 2012 Jan-Mar;27(1):51-5. doi: 10.1097/NCQ.0b013e31822b4537.
PMID:21826027
Reference Type:Reference
Citation:Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
PMID:22579025
Reference Type:Reference
Citation:Weiner SG, Sarff AR, Esener DE, Shroff SD, Budhram GR, Switkowski KM, Mostofi MB, Barus RW, Coute RA, Darvish AH. Single-operator ultrasound-guided intravenous line placement by emergency nurses reduces the need for physician intervention in patients with difficult-to-establish intravenous access. J Emerg Med. 2013 Mar;44(3):653-60. doi: 10.1016/j.jemermed.2012.08.021. Epub 2012 Oct 25.
PMID:23103067
Reference Type:Reference
Citation:de Graaff JC, Cuper NJ, Mungra RA, Vlaardingerbroek K, Numan SC, Kalkman CJ. Near-infrared light to aid peripheral intravenous cannulation in children: a cluster randomised clinical trial of three devices. Anaesthesia. 2013 Aug;68(8):835-45. doi: 10.1111/anae.12294. Epub 2013 Jun 14.
PMID:23763614
Reference Type:Reference
Citation:Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
PMID:23141920
Reference Type:Reference
Citation:Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.
PMID:22795988
Reference Type:Reference
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.
PMID:16271677
Reference Type:Reference
Citation:Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
PMID:18824276
Reference Type:Reference
Citation:Liu YT, Alsaawi A, Bjornsson HM. Ultrasound-guided peripheral venous access: a systematic review of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):18-23. doi: 10.1097/MEJ.0b013e328363bebc. Review.
PMID:23880981
Reference Type:Reference
Citation:Witting MD, Schenkel SM, Lawner BJ, Euerle BD. Effects of vein width and depth on ultrasound-guided peripheral intravenous success rates. J Emerg Med. 2010 Jul;39(1):70-5. doi: 10.1016/j.jemermed.2009.01.003. Epub 2009 Mar 9.
PMID:19272730
Reference Type:Reference
Citation:Sebbane M, Claret PG, Lefebvre S, Mercier G, Rubenovitch J, Jreige R, Eledjam JJ, de La Coussaye JE. Predicting peripheral venous access difficulty in the emergency department using body mass index and a clinical evaluation of venous accessibility. J Emerg Med. 2013 Feb;44(2):299-305. doi: 10.1016/j.jemermed.2012.07.051. Epub 2012 Sep 13.
PMID:22981661
Reference Type:Reference
Citation:Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.
PMID:21067078
Reference Type:Reference
Citation:Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.
PMID:22415409
Reference Type:Reference
Citation:Sun CY, Lee KC, Lin IH, Wu CL, Huang HP, Lin YY, Hsu YF, Yu HR. Near-infrared light device can improve intravenous cannulation in critically ill children. Pediatr Neonatol. 2013 Jun;54(3):194-7. doi: 10.1016/j.pedneo.2012.12.012. Epub 2013 Feb 1.
PMID:23597539
Reference Type:Reference
Citation:Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.
PMID:25176152
Reference Type:Reference
Citation:Fields JM, Piela NE, Au AK, Ku BS. Risk factors associated with difficult venous access in adult ED patients. Am J Emerg Med. 2014 Oct;32(10):1179-82. doi: 10.1016/j.ajem.2014.07.008. Epub 2014 Jul 30.
PMID:25171796

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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