Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department

Not Applicable

• Conditions: Patients With Difficult Vascular Access.
• Interventions: Procedure: Single Operator Ultrasound Guided IV placement; Procedure: Dual Operator Ultrasound Guided IV placement

• Registration Number: NCT02806180
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

This is a randomized controlled trial comparing the success of US guided peripheral IV placement between single vs dual-operator technique among a convenience sample of patients with moderate or difficult vascular access in a tertiary care Emergency Department.

Detailed Description

Gaining intravenous (IV) access is a common and important procedure in the emergency department (ED). IV access is needed to deliver drugs, enable fluid resuscitation and sample blood, and delays in gaining access can lead to patient harm. Ultrasound (US) is a commonly used tool in the ED, and the utility of ultrasound in the placement of IVs in patients with difficult access has been well described. This study aims to further guide the use of this evidence based tool by ED Registered Nurses. The focus will be comparing single-operator technique, in which the same provider manipulates the ultrasound probe while simultaneously placing the IV, to a dual-operator technique whereby a second provider manipulates the probe. Any measured advantage has implications in guiding education and practice, as well as informing future ED policy.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-15
• Study First Posted: 2016-06-20
• Last Update Posted: 2016-06-20
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Adult (18 years and older) patients predicted to require intravenous cannulas and identified at triage as having moderate or difficult access based on the following criteria:

Moderate: peripheral vein is visible or palpable but difficulty is expected based on patient characteristics both clinical and historical.

Difficult: No peripheral veins visible or palpable, or two failed attempts by traditional landmarking (LM).

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Exclusion Criteria

• Exclusion criteria will include patients who have already undergone successful pre-hospital IV placement, patients with an indwelling vascular device, patients who are critically ill (Canadian Triage Acuity Score I) or objection to study enrolment by the attending MD for any reason. If no suitable target vein can be identified with US the patient data will be collected and the patient will be excluded from the statistical analysis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-Operator	Single Operator Ultrasound Guided IV placement	For the 'Single Operator Ultrasound Guided IV placement' arm the RN operator will use the ultrasound probe to identify the target vein, and continue to hold and adjust the probe while placing the IV.
Dual-Operator	Dual Operator Ultrasound Guided IV placement	For the 'Dual Operator Ultrasound Guided IV placement' arm the RN operator will use the US to identify the target vein, at which time the study coordinator will hold the ultrasound probe in position. The RN operator will then place the IV.

Primary Outcome Measures

Name	Time	Method
First Pass Success	Total procedure time (<15 minutes)	The proportion of patients in whom vascular access is obtained on the first attempt with a single skin puncture.

Secondary Outcome Measures

Name	Time	Method
Overall Success	Total procedure time (<15 minutes)	The proportion of patients in whom vascular access is achieved within a maximum of three attempts at US guided placement.
Number of Attempts	Total procedure time (<15 minutes)	Total number of individual skin punctures that a patient receives.
Time to Canulation	Total procedure time (<15 minutes)	Measured as the time from when the Registered Nurse operator first picks up the ultrasound probe to the time when 'flashback' is seen to confirm placement.
Patient Pain Score	Total procedure time (<15 minutes)	To be completed by the patient immediately after the procedure: 10cm visual analogue scale from 'painless' to 'very painful'.
Operator Ease of Use Score	Total procedure time (<15 minutes)	To be completed by the Registered Nurse operator immediately after the procedure: 10cm visual analogue scale from 'very easy' to 'very difficult'.