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

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05119673
• Other study ID #: POCUS-DiffAcc
• Status: Completed
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: May 2023
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Vascular Access

Intervention

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.

Locations

Country	Name	City	State
Italy	Emergency Department, Città della Salute e della Scienza di Torino Univeristy Hospital	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Butterfly Network

Country where clinical trial is conducted

Italy, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of attempts of each peripheral i.v. access placement	The number of attempts needed for getting a peripheral i.v. access will be measured	Through study completion, likely of 1 year and half
Primary	Time needed for each peripheral i.v. access placement	Time needed for for getting a peripheral i.v. access will be measured	Through study completion, likely of 1 year and half