Vascular Access ComplicationNCT02618252
Ultrasound vs Veinviewer in Patients With Difficulty IV Access
A study testing Zonare and Veinviewer in people with Vascular Access Complication, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Zonare and Veinviewer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 5 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention
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.
Read the 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 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.
- Conditions
- Vascular Access Complication
- Being tested
- Zonare, Veinviewer
- Keywords
- difficult IV access, ultrasound, veinviewer, near infrared device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZonareDevice
Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
VeinviewerDevice
Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
| Study group | Role | What they receive |
|---|---|---|
| Zonare | Experimental | 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. Receives: Device: Zonare |
| Veinviewer | Experimental | 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. Receives: Device: Veinviewer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operator's time
time from equipment-in-room to successful aspiration of 3ml of blood
Measured: up to 40 minutes
Secondary outcomes (9)
Number of first successful attempts
operators have up to 40 minutes or 3 attempts.
Measured: 40 minutes
Number of failures
operators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality
Measured: 40 minutes
IV size
operators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge
Measured: 40 minutes
Patient satisfaction
after completion of IV cannulation
Measured: up to 40 minutes
Patient's perception of pain
after completion of IV cannulation
Measured: up to 40 minutes
ED length of stay
Length of stay for discharged patients.
Measured: 24 hours
hospital length of stay for admitted patient
Length of stay for admitted patients
Measured: 30 days
Cannulation time
time from applying tourniquet to successful aspiration of 3ml of blood.
Measured: 40 minutes
Number of failure to cannulate
operators have up to 40 minutes or 3 attempts.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start1 Aug 2016
- Primary completion5 May 2025
- Study completion5 May 2025
Why it stopped: We were not able to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quincy Tran, University of Maryland, Baltimore
- Investigators
- Quincy Tran, MD, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618252
- Sponsor's protocol ID
- HP-00065438
- Status last verified
- Nov 2025
- First submitted
- 4 Nov 2015
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. doi: 10.1016/j.jen.2003.11.004.
PubMed 14765078Witting 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.
PubMed 22137793Bauman 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.
PubMed 19371518Maiocco 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.
PubMed 21826027Teismann 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.
PubMed 22579025Weiner 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.
PubMed 23103067de 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.
PubMed 23763614Shokoohi 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.
PubMed 23141920Au 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.
PubMed 22795988Costantino 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.
PubMed 16271677Stein 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.
PubMed 18824276Liu 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.
PubMed 23880981Witting 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.
PubMed 19272730Sebbane 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.
PubMed 22981661Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.
PubMed 21067078
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention
- ClinicalTrials.gov ID
- NCT02618252
- Acronym / sponsor ID
- HP-00065438
- Conditions
- Vascular Access Complication
- Keywords
- difficult IV access, ultrasound, veinviewer, near infrared device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were not able to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zonare | Experimental | Device: Zonare108 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. |
| Veinviewer | Experimental | Device: Veinviewer108 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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 :
- Patients who do not speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZonarePatients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine. | Device | Zonare |
| VeinviewerPatients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine. | Device | Veinviewer |
Primary outcome
Operator's time
Time frame: up to 40 minutes
time from equipment-in-room to successful aspiration of 3ml of blood
9 secondary outcomes
Number of first successful attempts
Time frame: 40 minutes
Number of failures
Time frame: 40 minutes
IV size
Time frame: 40 minutes
Patient satisfaction
Time frame: up to 40 minutes
Patient's perception of pain
Time frame: up to 40 minutes
ED length of stay
Time frame: 24 hours
hospital length of stay for admitted patient
Time frame: 30 days
Cannulation time
Time frame: 40 minutes
Number of failure to cannulate
Time frame: 40 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Background: PubMed 14765078Tanabe 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. doi: 10.1016/j.jen.2003.11.004.
- Background: PubMed 22137793Witting 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.
- Background: PubMed 19371518Bauman 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.
- Background: PubMed 21826027Maiocco 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.
- Background: PubMed 22579025Teismann 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.
- Background: PubMed 23103067Weiner 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.
- Background: PubMed 23763614de 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.
- Background: PubMed 23141920Shokoohi 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.
- Background: PubMed 22795988Au 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.
- Background: PubMed 16271677Costantino 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.
- Background: PubMed 18824276Stein 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.
- Background: PubMed 23880981Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quincy Tran, MD, PhD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zonare and Veinviewer in people with Vascular Access Complication, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operator's time (time frame: up to 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618252, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.