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OpenTrials
Completed

NCT Number: NCT05119673

POCUS for Difficult Peripheral Access in the Emergency Department - a RCT

Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). The research hypothesis is that a biplane sonographic approach (i.e., an out-of-plane and in-plane view) might be superior to a mono-plane approach (i.e., an out-of-plane or in-plane view) obtaining a peripheral vascular access among difficult patients admitted to the ED

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department, Città della Salute e della Scienza di Torino Univeristy Hospital

Turin, Italy

About this study

Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). In some studies, difficult vascular access population was about 33% of evaluated patients and for most of them the "blind" method (i.e., palpation) fails in the line insertion. Ultrasound guidance often increase the success rate among these patients.

Two basic techniques were proposed for sonographic guidance, a transversal or a longitudinal approach to the chosen vessel (i.e., out-of-plane or in-plane view, respectively, "mono-plane" approach).

The availability of hand-held sonographic devices is increasing the number of emergency department were this guidance is used in a difficult vascular access population.

The Butterly iQ+ device is now able to show out-of-plane and in-plane views, simultaneously, the so called bi-plane view.

Aim of this randomized controlled trial is to test if a bi-plane sonographic vision might be able to increase the performance of trained operators in obtaining a peripheral vascular access among difficult patients admitted to the ED.

The present study will be a randomized controlled, 2-arm, nonblinded trial held at the Città della Salute e della Scienza di Torino, University hospital, Turin, Italy.

All healthcare workers already trained in ultrasound-guided vascular access will be considered eligible for the study (i.e., emergency physicians, residents, nurses) after an ad hoc brief (2 hours) training on the study.

This will be a "real world" study, each provider will be free of choosing the device he/she thought appropriate for each patient (in terms of length, gauge, type - peripheral midline will be included in the Italian center).

Using a computerized permuted blocks of random sizes, enrolled patients will be randomized in a 1:1 ratio to be evaluated using either the "standard" ultrasound-guided approach (out-of-place or in-plane view) or the bi-plane view (i.e. out-of-place and in-plane view, simultaneously).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

at least one of the following criteria have to be present along with the need for a peripheral access

  • chronic renal disease/ongoing dialysis;
  • sickle cell anemia;
  • prolonged and/or frequent use of i.v. drugs;
  • difficult vascular access (after a first attempt or self-reported);
  • previously need for more than one attempts / ultrasound guidance for getting a peripheral vascular access.

Exclusion criteria

  • no consent to participate in the study.

Treatment and study plan

bi-plane sonographic view to difficult peripheral vascular access using Butterfly iQ+®

Other

Bi-plane Butterfly iQ+® sonographic visualization will be used to help Emergency Department operators to get a venous peripheral access in a population of patients considered difficult for this task based on their history or the present clinical situation.

Primary outcomes

  1. number of attempts of each peripheral i.v. access placement

    Time frame: Through study completion, likely of 1 year and half

    The number of attempts needed for getting a peripheral i.v. access will be measured

  2. Time needed for each peripheral i.v. access placement

    Time frame: Through study completion, likely of 1 year and half

    Time needed for for getting a peripheral i.v. access will be measured

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Butterfly Network

Registry information

Official study title

Point-of-care Ultrasound for Difficult Peripheral Vascular Access in the Emergency Department - a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2021
Registry last updated
May 9, 2023

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.

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