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Evaluate Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Peripheral Intravenous Access

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ClinicalTrials.gov Identifier: NCT01859559
Recruitment Status : Completed
First Posted : May 22, 2013
Last Update Posted : December 7, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Melissa McCarthy, George Washington University

Brief Summary:

The primary objective of this randomized controlled trial (RCT) is to compare the success rate of obtaining peripheral vascular access with ultrasound guidance versus the traditional, landmark approach among patients with varying degrees of intravenous access difficulty. In addition to comparing overall initial success rates of the two methods, we will also compare the success rates by degree of intravenous access difficulty (3 main subject subgroups) and by operator experience (approximately 20 emergency department technicians).

The main hypothesis is that the initial success rate will be significantly higher (5% or greater) for ultrasound guided peripheral intravenous access compared to landmark approach among patients who are judged to have difficult intravenous access but no significant difference (i.e. < 5%) among patients judged to have easy intravenous access.


Condition or disease Intervention/treatment Phase
Patients With Peripheral Intravenous Access Lines Procedure: Ultrasound-guided peripheral intravenous access line placement Procedure: Landmark Approach to peripheral intravenous access line placement Not Applicable

Detailed Description:

This is a randomized controlled trial with a two group parallel design that will compare the initial success rate of peripheral intravenous line (PIV) placement between the traditional, landmark approach versus ultrasound guided. Emergency department (ED) patients who are in a treatment room and require a PIV line are eligible for the study. For those who are eligible, the ED technician and an ED nurse will each complete a clinical data sheet that documents the degree of IV access difficulty.

For those who enroll, the research assistant (RA) will randomize the subject to one of two treatment groups: (1) ultrasound guided or; (2) landmark approach. The ED technician will perform the PIV placement based on the treatment group assigned through the randomization process. The RA will be present during the PIV placement and will ask the patient prior to the procedure about factors that may influence IV access (i.e. self-reported weight and height, presence of chronic conditions). The RA will also document the ED outcomes of the procedure (i.e. duration of procedure, success or failure, complications of procedure) and query the patient on the extent of discomfort associated with the procedure. Finally, for those subjects who are admitted to the hospital, a RA will conduct follow-up on the PIV line to determine how long it is used on the ward and the reason for taking it out (i.e. no longer needed, infection, infiltration, fell out, etc). It is hospital policy that PIV lines be changed every 72 hours to prevent infection so we anticipate that the maximum follow-up of each ED PIV line placed will be 72 hours.

There are two treatment groups, the ultrasound guided treatment group and the traditional, landmark group. For both treatment groups, a tourniquet will be placed above the upper extremity vein chosen for cannulation. For the landmark approach, the ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the IV line. If the patient is randomized to the ultrasound group, the operator will use ultrasound to help visualize the vein and direct line placement. When using ultrasound, the ED technicians will employ a one-person technique. For both treatment groups, if the first attempt fails, we will randomize the subject again to one of the two treatment arms. We are randomizing a second time because failure at first attempt is a good marker of the difficulty of the procedure. By randomizing a second time, we will be able to determine whether either method is superior after one failed attempt. After the second failed attempt, the ED technician can use whatever method he/she chooses to place the line.

Because of the nature of the intervention, this RCT is unblinded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial To Compare The Initial Success Rate of Ultrasound Guided Versus Landmark Approach For Placement of Peripheral Intravenous Access Lines in Emergency Department Patients
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: Easy Access
This arm will included emergency department patients that are judged to have easy intravenous access in at least one of the upper extremities by the ED technician.
Procedure: Ultrasound-guided peripheral intravenous access line placement
The ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique.

Procedure: Landmark Approach to peripheral intravenous access line placement
ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity.

Experimental: Difficult Access By Clinician Judgment
This arm will include patients that at least one vein is visible or palpable in one of the upper extremities but either the ED technician and/or ED nurse judges the patient to have difficult intravenous access.
Procedure: Ultrasound-guided peripheral intravenous access line placement
The ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique.

Procedure: Landmark Approach to peripheral intravenous access line placement
ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity.

Experimental: Non visible and Non palpable
This arm will include patients for whom neither the ED technician nor an ED nurse can identify a visible or palpable vein that is suitable for an intravenous access line in either upper extremity.
Procedure: Ultrasound-guided peripheral intravenous access line placement
The ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique.

Procedure: Landmark Approach to peripheral intravenous access line placement
ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity.




Primary Outcome Measures :
  1. Initial success rate [ Time Frame: immediatetely after first attempt, average attempt takes 15 minutes ]
    A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture.


Secondary Outcome Measures :
  1. Any complications associated with the PIV line [ Time Frame: within ED visit, average ED length of stay is 6 hours ]
    Incidence of infiltration, arterial puncture, or nerve puncture


Other Outcome Measures:
  1. Numeric Rating of Pain Associated with insertion of PIV line [ Time Frame: within 5 minutes of final PIV placement, average placement take < 30 minutes ]
    Patient-reported measure of pain associated with the insertion of the PIV line using the Numeric Rating Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • peripheral venous (PIV) access line ordered by a physician during their emergency department visit.

Exclusion Criteria:

  • Non-English or non-spanish speaking
  • already enrolled in a different study during the ED visit
  • too sick, patient requires intravenous access quickly and can not take the time to enroll in 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): NCT01859559


Locations
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United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Johns Hopkins University
Investigators
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Principal Investigator: Melissa L McCarthy, ScD George Washington University
Principal Investigator: Hamid Shokoohi, MD George Washington University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Melissa McCarthy, Associate Professor, George Washington University
ClinicalTrials.gov Identifier: NCT01859559    
Other Study ID Numbers: PIV-RCT-ED
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Keywords provided by Melissa McCarthy, George Washington University:
ultrasound
peripheral intravenous access
operator experience