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Ultrasound-guided Peripheral Intravenous Catheter Insertion Technique (PIVC)

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ClinicalTrials.gov Identifier: NCT04218643
Recruitment Status : Enrolling by invitation
First Posted : January 6, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
The Reading Hospital and Medical Center

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.

Condition or disease Intervention/treatment Phase
Catheterization, Peripheral Venous Phlebitis Infiltration Other: Ultrasound-guided technique Other: Standard technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective trial comparing US-guided PIVC insertion with standard PIVC insertion technique
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ultrasound-guided Peripheral Intravenous Catheter Insertion Technique and the Effects on Overall Site Utilization and Failure
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Standard technique
Intravenous catheter inserted via standard technique
Other: Standard technique
IV inserted via standard technique

Experimental: Ultrasound-guided technique
Intravenous catheter inserted via ultrasound guidance
Other: Ultrasound-guided technique
IV inserted via ultrasound guidance




Primary Outcome Measures :
  1. Post insertion failure rates [ Time Frame: Duration of catheter dwell time (up to 168 hours) ]
    Failure rate (overall and individual cause/reason)

  2. Overall utility [ Time Frame: Up to 168 hours (1 week) ]
    The overall dwell time of the catheter


Secondary Outcome Measures :
  1. Post removal complication rates [ Time Frame: 48 hours after catheter removal ]
    Determining if ultrasound-guided peripheral intravenous catheter insertion results in lower post removal complication rates compared to PIVCs inserted in the standard manner.

  2. Catheter to vein ratio [ Time Frame: Up to 168 hours (1 week) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04218643


Locations
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United States, Pennsylvania
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Sponsors and Collaborators
The Reading Hospital and Medical Center
Investigators
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Principal Investigator: Scott Leroux, BS NRP Reading Hospital
Publications:
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

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Responsible Party: The Reading Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04218643    
Other Study ID Numbers: IRB 042-19
First Posted: January 6, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Reading Hospital and Medical Center:
peripheral intravenous catheter
ultrasound-guided
IV insertion
catheter to vein ratio
Additional relevant MeSH terms:
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Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis