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

NCT04821362 | Completed Results

• 1 other identifier: 18-7/32
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vascular Access

Keywords

peripheral intravenous catheter; near infrared; ultrasound

Outcome Measures

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

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

Secondary Outcomes (3)

• Procedure Time.

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

• Patients Who Need Rescue Methods

  Up to 1 hour.

• Number of Attempts

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

Study Arms (3)

Standard technique group

NO INTERVENTION

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

Ultrasound group

ACTIVE COMPARATOR

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

Device: Ultrasound group

Near Infrared Device Group

ACTIVE COMPARATOR

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

Device: Near Infrared Device Group

Interventions

Ultrasound group DEVICE

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

Ultrasound group

Near Infrared Device Group DEVICE

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

Near Infrared Device Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 10577399 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 19912132 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 27411965 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 28983903 BACKGROUND

Results Point of Contact

• Title: Dr. Sercan Yalçınlı
• Organization: Ege University

sercan.yalcinli@ege.edu.tr

+90 505 537 41 01

Study Officials

• Özge Can, MD

  Ege University

  PRINCIPAL INVESTIGATOR

• İlhan Uz, MD

  Ege University

  PRINCIPAL INVESTIGATOR

• Gülbin Konakçı, Asst. Prof.

  Izmir Demokrasi University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, MD

Model Details: A prospective, experimental, randomized controlled trial.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: March 29, 2021
• Study Start: April 15, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)