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

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.

Study Overview

• Status: Unknown
• Conditions: Patients With Difficult Vascular Access.
• Intervention / Treatment: Procedure: Single Operator Ultrasound Guided IV placement; Procedure: Dual Operator Ultrasound Guided IV placement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single-Operator; 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.	Procedure: Single Operator Ultrasound Guided IV placement; Single operator holds ultrasound probe and places IV.
EXPERIMENTAL: Dual-Operator; 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.	Procedure: Dual Operator Ultrasound Guided IV placement; Second operator holds ultrasound probe.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Jordan Chenkin, MD, FRCPC, Sunnyrbook Health Science Centre, University of Toronto

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 410001002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO