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

June 15, 2016 updated by: Dr. Jordan Chenkin, Sunnybrook Health Sciences Centre
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
First Pass Success
Time Frame: Total procedure time (<15 minutes)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Success
Time Frame: 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.
Total procedure time (<15 minutes)
Number of Attempts
Time Frame: Total procedure time (<15 minutes)
Total number of individual skin punctures that a patient receives.
Total procedure time (<15 minutes)
Time to Canulation
Time Frame: 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.
Total procedure time (<15 minutes)
Patient Pain Score
Time Frame: Total procedure time (<15 minutes)
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
Time Frame: 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'.
Total procedure time (<15 minutes)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunnybrook Health Sciences Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordan Chenkin, MD, FRCPC, Sunnyrbook Health Science Centre, University of Toronto

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 410001002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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