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Completed

NCT Number: NCT01859559

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided peripheral intravenous access line placement

Procedure

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.

Landmark Approach to peripheral intravenous access line placement

Procedure

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Johns Hopkins University

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2013
Registry last updated
Dec 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.