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

May 8, 2023 updated by: Emanuele Pivetta, University of Turin, Italy

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

442

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: mono-plane sonographic view
Usual standard of care, in our institution, for difficult peripheral vascular access in the Emergency Department.
Active Comparator: bi-plane sonographic view
Other: bi-plane sonographic view to difficult peripheral vascular access using Butterfly iQ+®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, likely of 1 year and half
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
Through study completion, likely of 1 year and half

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Collaborators

Butterfly Network

Investigators

  • Principal Investigator: Emanuele Pivetta, MD,PhD, Città della Salute e della Scienza di Torino University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2021

Primary Completion (Actual)

May 11, 2022

Study Completion (Actual)

May 11, 2022

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POCUS-DiffAcc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Emergencies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe