Ultrasound-guided Peripheral Intravenous Catheter Insertion Technique

NCT04218643 | Terminated

• 1 other identifier: IRB 042-19
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

This comparative treatment study aims to challenge a current clinical practice. Specifically, whether the use of ultrasound-guided peripheral intravenous catheter insertion results in lower post insertion failure rates with longer utility time compared to peripheral intravenous catheters (PIVC) inserted in the standard manner during the emergency department (ED), observation and in-patient stay. There are two secondary aims to the study: a) determining if ultrasound-guided peripheral intravenous catheter insertion results in lower post removal complication rates compared to PIVCs inserted in the standard manner; and b) determining if catheter-to-vein ratio can predict post insertion success of PIVCs and what catheter-to-vein ratio is most successful. In this study, catheter-to-vein ratio is defined as the diameter of the lumen of the vein divided by the outside diameter of the catheter.

Conditions

Catheterization, Peripheral Venous; Phlebitis; Infiltration

Keywords

peripheral intravenous catheter; ultrasound-guided; IV insertion; catheter to vein ratio

Outcome Measures

Primary Outcomes (2)

• Post insertion failure rates

  Failure rate (overall and individual cause/reason)

  Duration of catheter dwell time (up to 168 hours)

• Overall utility

  The overall dwell time of the catheter

  Up to 168 hours (1 week)

Secondary Outcomes (2)

• Post removal complication rates

  48 hours after catheter removal

• Catheter to vein ratio

  Up to 168 hours (1 week)

Study Arms (2)

Standard technique

ACTIVE COMPARATOR

Intravenous catheter inserted via standard technique

Other: Standard technique

Ultrasound-guided technique

EXPERIMENTAL

Intravenous catheter inserted via ultrasound guidance

Other: Ultrasound-guided technique

Interventions

Ultrasound-guided technique OTHER

IV inserted via ultrasound guidance

Ultrasound-guided technique

Standard technique OTHER

IV inserted via standard technique

Standard technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Identified as requiring a PIVC
• Acceptable vital signs - not requiring emergent resuscitation

You may not qualify if:

• Patients triaged as MI alert, brain attack alert, and trauma alert
• Pregnant
• Prisoners
• Institutionalized patients
• Housing insecurity
• Unable to provide consent
• Previously entered into the study

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead

Study Sites (1)

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Related Publications (14)

• Braga LM, Parreira PM, Oliveira ASS, Monico LDSM, Arreguy-Sena C, Henriques MA. Phlebitis and infiltration: vascular trauma associated with the peripheral venous catheter. Rev Lat Am Enfermagem. 2018;26:e3002. doi: 10.1590/1518-8345.2377.3002. Epub 2018 May 17.

  PMID: 29791668 BACKGROUND

• Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.

  PMID: 25871866 BACKGROUND

• Marsh N, Webster J, Larson E, Cooke M, Mihala G, Rickard CM. Observational Study of Peripheral Intravenous Catheter Outcomes in Adult Hospitalized Patients: A Multivariable Analysis of Peripheral Intravenous Catheter Failure. J Hosp Med. 2018 Feb 1;13(2):83-89. doi: 10.12788/jhm.2867. Epub 2017 Oct 18.

  PMID: 29073316 BACKGROUND

• Murayama R, Uchida M, Oe M, Takahashi T, Oya M, Komiyama C, Sanada H. Removal of Peripheral Intravenous Catheters Due to Catheter Failures Among Adult Patients. J Infus Nurs. 2017 Jul/Aug;40(4):224-231. doi: 10.1097/NAN.0000000000000168.

  PMID: 28683001 BACKGROUND

• Miliani K, Taravella R, Thillard D, Chauvin V, Martin E, Edouard S, Astagneau P; CATHEVAL Study Group. Peripheral Venous Catheter-Related Adverse Events: Evaluation from a Multicentre Epidemiological Study in France (the CATHEVAL Project). PLoS One. 2017 Jan 3;12(1):e0168637. doi: 10.1371/journal.pone.0168637. eCollection 2017.

  PMID: 28045921 BACKGROUND

• Yabunaka K, Murayama R, Tanabe H, et al. Ultrasonographic classification of subcutaneous edema caused by infusion via peripheral intravenous catheter. Journal of Medical Ultrasound. 2016;24(2):60-5. doi: org/10.1016/j.jmu.2016.02.001

  BACKGROUND

• 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. doi: 10.1016/j.annemergmed.2004.12.026.

  PMID: 16271677 BACKGROUND

• Stolz LA, Stolz U, Howe C, Farrell IJ, Adhikari S. Ultrasound-guided peripheral venous access: a meta-analysis and systematic review. J Vasc Access. 2015 Jul-Aug;16(4):321-6. doi: 10.5301/jva.5000346. Epub 2015 Feb 4.

  PMID: 25656255 BACKGROUND

• Tanabe H, Takahashi T, Murayama R, Yabunaka K, Oe M, Matsui Y, Arai R, Uchida M, Komiyama C, Sanada H. Using Ultrasonography for Vessel Diameter Assessment to Prevent Infiltration. J Infus Nurs. 2016 Mar-Apr;39(2):105-11. doi: 10.1097/NAN.0000000000000159.

  PMID: 26934164 BACKGROUND

• Spencer TR, Mahoney KJ. Reducing catheter-related thrombosis using a risk reduction tool centered on catheter to vessel ratio. J Thromb Thrombolysis. 2017 Nov;44(4):427-434. doi: 10.1007/s11239-017-1569-y.

  PMID: 29022210 BACKGROUND

• Nifong TP, McDevitt TJ. The effect of catheter to vein ratio on blood flow rates in a simulated model of peripherally inserted central venous catheters. Chest. 2011 Jul;140(1):48-53. doi: 10.1378/chest.10-2637. Epub 2011 Feb 24.

  PMID: 21349931 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

  PMID: 36507736 DERIVED

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• Scott Leroux, BS NRP

  Reading Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective trial comparing US-guided PIVC insertion with standard PIVC insertion technique

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: January 6, 2020
• Study Start: February 11, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 30, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)