Patients With Difficult Vascular Access.NCT02806180
Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department
A study testing Dual Operator Ultrasound Guided IV placement and Single Operator Ultrasound Guided IV placement in people with Patients With Difficult Vascular Access., run by Sunnybrook Health Sciences Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Difficult Vascular Access.
- What is being tested?
- Dual Operator Ultrasound Guided IV placement and Single Operator Ultrasound Guided IV placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Patients With Difficult Vascular Access.
- Being tested
- Dual Operator Ultrasound Guided IV placement, Single Operator Ultrasound Guided IV placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Operator Ultrasound Guided IV placementProcedure or surgery
Second operator holds ultrasound probe.
Single Operator Ultrasound Guided IV placementProcedure or surgery
Single operator holds ultrasound probe and places IV.
| Study group | Role | What they receive |
|---|---|---|
| Single-Operator | Experimental | 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. Receives: Procedure: Single Operator Ultrasound Guided IV placement |
| Dual-Operator | Experimental | 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. Receives: Procedure: Dual Operator Ultrasound Guided IV placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Pass Success
The proportion of patients in whom vascular access is obtained on the first attempt with a single skin puncture.
Measured: Total procedure time (<15 minutes)
Secondary outcomes (5)
Overall Success
The proportion of patients in whom vascular access is achieved within a maximum of three attempts at US guided placement.
Measured: Total procedure time (<15 minutes)
Number of Attempts
Total number of individual skin punctures that a patient receives.
Measured: 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.
Measured: 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'.
Measured: 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'.
Measured: Total procedure time (<15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Difficult Vascular Access.Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jordan Chenkin, Sunnybrook Health Sciences Centre
- Investigators
- Jordan Chenkin, MD, FRCPC, Principal investigator, Sunnyrbook Health Science Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806180
- Sponsor's protocol ID
- 410001002
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single v Dual-Operator Ultrasound Technique for Peripheral Vascular Access in the Emergency Department
- ClinicalTrials.gov ID
- NCT02806180
- Acronym / sponsor ID
- 410001002
- Conditions
- Patients With Difficult Vascular Access.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Operator | Experimental | Procedure: Single Operator Ultrasound Guided IV placementFor 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 | Experimental | Procedure: Dual Operator Ultrasound Guided IV placementFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Operator Ultrasound Guided IV placementSecond operator holds ultrasound probe. | Procedure or surgery | Dual-Operator |
| Single Operator Ultrasound Guided IV placementSingle operator holds ultrasound probe and places IV. | Procedure or surgery | Single-Operator |
Primary outcome
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.
5 secondary outcomes
Overall Success
Time frame: Total procedure time (<15 minutes)
Number of Attempts
Time frame: Total procedure time (<15 minutes)
Time to Canulation
Time frame: Total procedure time (<15 minutes)
Patient Pain Score
Time frame: Total procedure time (<15 minutes)
Operator Ease of Use Score
Time frame: Total procedure time (<15 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Chenkin, MD, FRCPC principal investigator
Sunnyrbook Health Science Centre, University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Dual Operator Ultrasound Guided IV placement and Single Operator Ultrasound Guided IV placement in people with Patients With Difficult Vascular Access., run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Brick, MD (6473281755, craig.brick@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Pass Success (time frame: Total procedure time (<15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.