CClinicalTrials.gg
CompletedNCT04821362Updated Dec 3, 2021Results posted

Comparison of Different Techniques on First Attempt Success in Difficult Vascular Access Patients

An interventional study of Ultrasound group and Near Infrared Device Group in Vascular Access, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by Ege University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this study is to investigate whether there is any difference between the use of standard techniques, ultrasonography and infra-red light for the success of the first attempt in difficult peripheral vascular access patients. Patients who have difficult vascular access history ( often need 2 or more attempt to access peripheral intravenous catheter), who do not have palpable or visible vein after tourniquet, and who have the hard anticipation according to operator ( easy-moderate-hard) are included to study. The primary objective is planned as the determination of the success rate in the first attempt. Secondary aims of the study were determined as: total procedure time,total number of attempts, and need for rescue procedure

Read the detailed description

Before starting the study, all nurses who work as senior nurse in the emergency department will be informed. All the Emergency Nurses who are willing to participate in the study (the consent form from the nurses who will be included in the study) will be taken pretest to measure their knowledge about ultrasound and infrared light usage for intravenous access. Then, the 4-hours theoretical and 4-hours practical lesson accompanied by an infrared device and a single-operator with horizontal and longitudinal vascular access with ultrasonography will be explained by the experienced Emergency Medicine Specialist to all the senior nurses . Introduction of ultrasonography device in the theoretical training, principles of using, linear probe and its properties, horizontal and longitudinal axis concepts used in the determination of venous structures, principles of determination of venous structures in ultrasonography, differentiation of artery and nerve structures will be explained. The introduction of the device for infrared light, the principles of operation, the distance between the light and operation area and the positioning of the device will be discussed. Practical trainings will be arranged on horizontal and longitudinal axes by using ultrasound on lifeless forearm mannequin. In the practical lesson in the infrared light device, the device will be kept in a proper distance on the live mannequin, being positioned perpendicular to the area to be treated and identification of the vascular structures while the device is operating. After the theoretical and practical training, all of the senior nurses will be evaluated with posttest and the nurses with a success rate of 80% will be included in the study.

Adult patients and/ or their relatives will be included to study if they meet any of the inclusion criteria and accept the consent form. The randomization of the patients according to the number of nurses participating in the study will be determined by the responsible researchers before the study begins. For example, in the study where 10 senior nurses will participate, the number of targeted patients will be at least 270 and 10 boxes specific to each nurse will be created. These boxes will be kept in the senior nurse room. Each box will have 27 different application methods (9 usg, 9 infrared, 9 standard methods). The nurse who accepts to participate in the research will apply the method according to the procedure which will be randomly drawn from this box. In this way, an equal number of procedures will be provided for each nurse and an equal number of procedures will be provided for each nurse.

The application of the procedure on the longitudinal or horizontal axis will be left to senior nurse discretion. In the infrared light approach, 2 applicators will be operated. While holding the auxiliary infra-red light, the practitioner will perform the operation at a distance of 20 cm perpendicular to the process zone. The place of application will be left to the discretion of the practitioner. In order to establish a standard approach between the procedures performed, 18 gauge catheter will be used at the arm and the forearm areas, 20 gauge for the other regions. After the tourniquet is inserted, the procedure time will be calculated as seconds. In order for the successful vascular access to be considered successful, at least 5 ml of blood should be taken or at least 5 ml of saline fluid should be given. In all three approaches, if there is no success after 2 attempts, the 3rd and subsequent trials will be evaluated as rescue interventions and these interventions will be left to the discretion of the practitioner and this will be recorded observably (standard approach, usg, infra red light, central vascular, intraosseous approach, calling senior nurse, calling emergency medicine physician etc.). For all three approaches, the success of the first trial, the total duration of the procedure (in seconds), the total number of trials, and rescue method need will be recorded.

02

Conditions studied

  • Vascular Access

Keywords

  • peripheral intravenous catheter
  • near infrared
  • ultrasound
03

In context

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who have previously described a history of difficult vascular access.
  • Patients who do not have palpable or visible veins after tourniquet placement or who have been referred to unusual locations due to the lack of appropriate veins in the upper extremity.
  • Patients who are expected to be hard to perform the procedure by the senior nurse.

Exclusion criteria

Exclusion Criteria:

  • The patients who do not need vascular access.
  • Patients who do not give consent
  • Pregnant patients
  • Patients who are under 18 years old
  • Patients who require immediate intervention due to any life-threatening condition.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
270 participants (actual)

Study arms

  • No intervention
    Standard technique group

    In this group, peripheral intravenous catheter insertion will be performed routinely.

  • Active comparator
    Ultrasound group

    In this group, peripheral intravenous catheter insertion will be performed with ultrasound. A linear probe will be used for procedures.

    Device: Ultrasound group

  • Active comparator
    Near Infrared Device Group

    In this group, peripheral intravenous catheter insertion will be performed with AccuVein AV 400.

    Device: Near Infrared Device Group

Interventions

  • DeviceUltrasound group

    In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.

  • DeviceNear Infrared Device Group

    In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Success in the First Attempt

    The success numbers of the first attempt during the implementation of all three methods

    Time frame: From the time of randomization until the time of the first successful attempt, up to 30 minutes.

Secondary outcomes

  1. Procedure Time.

    Time of the intravenous catheter placement procedure

    Time frame: From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.

  2. Patients Who Need Rescue Methods

    The method used as a rescue method when the primary method fails to achieve success.

    Time frame: Up to 1 hour.

  3. Number of Attempts

    Number of attempts to successfully insert peripheral vascular cateter.

    Time frame: From the time of randomization until the time of the successful attempt, up to 1 hour.

07

Results

Posted Dec 3, 2021

Participant flow

Participant flow — Overall Study
MilestoneStandard Technique GroupUltrasound GroupNear Infrared Device Group
Started909090
Completed909090
Not completed000

Outcome measures

PrimaryNumber of Participants With Success in the First Attempt

The success numbers of the first attempt during the implementation of all three methods

Time frame:
From the time of randomization until the time of the first successful attempt, up to 30 minutes.
Reported as:
Count of participants · Participants
Number of Participants With Success in the First Attempt
ParticipantsStandard Technique GroupUltrasound GroupNear Infrared Device Group
Number of Participants With Success in the First Attempt567153
SecondaryProcedure Time.

Time of the intravenous catheter placement procedure

Time frame:
From the time of the tourniquet application, until the procedure successfully achieved, up to 1 hour.
Reported as:
Median · Seconds
Procedure Time.
SecondsStandard Technique GroupUltrasound GroupNear Infrared Device Group
Procedure Time.72 (47 to 134)107 (69 to 228)82 (61 to 163)
SecondaryPatients Who Need Rescue Methods

The method used as a rescue method when the primary method fails to achieve success.

Time frame:
Up to 1 hour.
Reported as:
Count of participants · Participants
Patients Who Need Rescue Methods
ParticipantsStandard Technique GroupUltrasound GroupNear Infrared Device Group
Patients Who Need Rescue Methods171725
SecondaryNumber of Attempts

Number of attempts to successfully insert peripheral vascular cateter.

Time frame:
From the time of randomization until the time of the successful attempt, up to 1 hour.
Reported as:
Median · attempts
Number of Attempts
attemptsStandard Technique GroupUltrasound GroupNear Infrared Device Group
Number of Attempts1 (1 to 2)1 (1 to 1)1 (1 to 2)

Adverse events

Collected over 1 hour. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Technique Group0/90 (0%)0/90 (0%)0/90 (0%)
Ultrasound Group0/90 (0%)0/90 (0%)0/90 (0%)
Near Infrared Device Group0/90 (0%)0/90 (0%)0/90 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Standard Technique GroupUltrasound GroupNear Infrared Device GroupTotal
<=18 years0000
Between 18 and 65 years414947137
>=65 years494143133
Age, Continuous
Age, Continuous(years)Standard Technique GroupUltrasound GroupNear Infrared Device GroupTotal
Median68.5 (51 to 76)64 (53 to 76)64 (49 to 77)65 (51 to 76)
Sex: Female, Male
Sex: Female, Male(Participants)Standard Technique GroupUltrasound GroupNear Infrared Device GroupTotal
Female565160167
Male343930103
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Standard Technique GroupUltrasound GroupNear Infrared Device GroupTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White909090270
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(Participants)Standard Technique GroupUltrasound GroupNear Infrared Device GroupTotal
Turkey909090270
08

Study locations

1 site
  • Ege University
    Izmir, Bornova 35030, Turkey
09

References and documents

Publications

  • Keyes LE, Frazee BW, Snoey ER, Simon BC, Christy D. Ultrasound-guided brachial and basilic vein cannulation in emergency department patients with difficult intravenous access. Ann Emerg Med. 1999 Dec;34(6):711-4. doi: 10.1016/s0196-0644(99)70095-8. PubMed 10577399 ↗
  • 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. PubMed 19371518 ↗
  • Panebianco NL, Fredette JM, Szyld D, Sagalyn EB, Pines JM, Dean AJ. What you see (sonographically) is what you get: vein and patient characteristics associated with successful ultrasound-guided peripheral intravenous placement in patients with difficult access. Acad Emerg Med. 2009 Dec;16(12):1298-1303. doi: 10.1111/j.1553-2712.2009.00520.x. Epub 2009 Nov 12. PubMed 19912132 ↗
  • 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. PubMed 22795988 ↗
  • Parker SI, Benzies KM, Hayden KA, Lang ES. Effectiveness of interventions for adult peripheral intravenous catheterization: A systematic review and meta-analysis of randomized controlled trials. Int Emerg Nurs. 2017 Mar;31:15-21. doi: 10.1016/j.ienj.2016.05.004. Epub 2016 Jul 11. PubMed 27411965 ↗
  • 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. PubMed 25176152 ↗
  • Hanada S, Van Winkle MT, Subramani S, Ueda K. Dynamic ultrasound-guided short-axis needle tip navigation technique vs. landmark technique for difficult saphenous vein access in children: a randomised study. Anaesthesia. 2017 Dec;72(12):1508-1515. doi: 10.1111/anae.14082. Epub 2017 Oct 6. PubMed 28983903 ↗

Study documents

  • Study protocol · Jul 3, 2018
  • Statistical analysis plan · Jul 3, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04821362
Lead sponsor
Ege University
Responsible party
Sercan Yalcinli (Attending Physician, MD, Ege University) — Principal investigator
First posted
Mar 29, 2021
Start date
Apr 15, 2019
Primary completion
Feb 1, 2020
Completion
Mar 1, 2020
Results posted
Dec 3, 2021
Last update
Dec 3, 2021

Study contacts

Özge Can, MD
principal investigator · Ege University
İlhan Uz, MD
principal investigator · Ege University
Gülbin Konakçı, Asst. Prof.
principal investigator · Izmir Demokrasi University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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