Catheter Related ComplicationNCT04811430
Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization: A Pilot Study
An observational study of Catheter Related Complication, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- Randomized Traditional and Cue(TM) Needle Tracking Technology
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2019to 15 Oct 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Emergency Department and Critical Care Nurses
Who may be able to join
- US-based emergency department nurse who have placed 10 peripheral intravenous catheters in the past 60 days
- have placed less than or equal to 15 ultrasound-assisted vascular access devices in the past 60 days and have been practicing ultrasound-assisted vascular access no more than 18 months
Who cannot join
- Nurses that don't meet that predetermined inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness, Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization for Midline Catheter Insertion: A Pilot Study
The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.
Read the detailed description
A pilot study using simulated tissue was conducted with 49 US-based emergency department nurses to compare insertion of a midline catheter using traditional ultrasound guidance versus an advanced needle-tracking technology along with traditional ultrasound guidance.
- Conditions
- Catheter Related Complication
- Being tested
- Randomized Traditional, Cue(TM) Needle Tracking Technology
- Keywords
- Visualization, Needle Guidance, Midline Catheter, Emergency Department Nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized TraditionalDevice
Also called Randomized Traditional Ultrasound method
Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients
Cue(TM) Needle Tracking TechnologyDevice
Cue(TM) Needle Tracking Technology with real time needle tip tracking is used to assist ultrasound guided midline insertions on simulated veins blocks not live patients
| Study group | Role | What they receive |
|---|---|---|
| Randomized Traditional | Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology Receives: Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology | |
| Radomized Cue Needle Tracking technology | Randomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology Receives: Device: Randomized Traditional; Device: Cue(TM) Needle Tracking Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Success
Number of attempts required to properly place a needle tip in the simulated vessel
Measured: 1 hour
Insertion Time
Time required to successfully insert a needle tip into a simulated vessel
Measured: 1 hour
Backwalling Events
Events where the needle fully transects the simulated blood vessel during the inserting of the needle tip into a simulated vessel
Measured: 1 hour
Needle redirects
Lateral movement and deflection of the needle tip during insertion into a simulated vessel
Measured: 1 hour
Accuracy of Needle Placement
Accuracy of needle placement as indicated by the lateral distance from a target
Measured: 1 hour
Secondary outcomes (1)
Self-reported subjective measurements
Post-study questions were used to assess confidence during insertion with Cue needle tracking system (likert), confidence when insertion with traditional ultrasound techniques (likert), preference between the cue needle tracking system and the standard of care
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start14 Oct 2019
- Primary completion14 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811430
- Sponsor's protocol ID
- P88008.0
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness, Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization for Midline Catheter Insertion: A Pilot Study
- ClinicalTrials.gov ID
- NCT04811430
- Acronym / sponsor ID
- P88008.0
- Conditions
- Catheter Related Complication
- Keywords
- Visualization, Needle Guidance, Midline Catheter, Emergency Department Nurse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 23 Mar 2021 (actual)
- 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.
The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.
Detailed description
A pilot study using simulated tissue was conducted with 49 US-based emergency department nurses to compare insertion of a midline catheter using traditional ultrasound guidance versus an advanced needle-tracking technology along with traditional ultrasound guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Traditional | – | Device: Randomized Traditional, Device: Cue(TM) Needle Tracking TechnologyRandomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology |
| Radomized Cue Needle Tracking technology | – | Device: Randomized Traditional, Device: Cue(TM) Needle Tracking TechnologyRandomized to traditional ultrasound guided peripheral insertion placement vs placement with Cue needle tracking technology |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Emergency Department and Critical Care Nurses
Key inclusion criteria (2 listed)
- US-based emergency department nurse who have placed 10 peripheral intravenous catheters in the past 60 days
- have placed less than or equal to 15 ultrasound-assisted vascular access devices in the past 60 days and have been practicing ultrasound-assisted vascular access no more than 18 months
Key exclusion criteria (1 listed)
- Nurses that don't meet that predetermined inclusion criteria
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 |
|---|---|---|
| Randomized TraditionalAlso: Randomized Traditional Ultrasound methodTraditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients | Device | Radomized Cue Needle Tracking technology, Randomized Traditional |
| Cue(TM) Needle Tracking TechnologyCue(TM) Needle Tracking Technology with real time needle tip tracking is used to assist ultrasound guided midline insertions on simulated veins blocks not live patients | Device | Radomized Cue Needle Tracking technology, Randomized Traditional |
Primary outcome
Insertion Success
Time frame: 1 hour
Number of attempts required to properly place a needle tip in the simulated vessel
Insertion Time
Time frame: 1 hour
Time required to successfully insert a needle tip into a simulated vessel
Backwalling Events
Time frame: 1 hour
Events where the needle fully transects the simulated blood vessel during the inserting of the needle tip into a simulated vessel
Needle redirects
Time frame: 1 hour
Lateral movement and deflection of the needle tip during insertion into a simulated vessel
Accuracy of Needle Placement
Time frame: 1 hour
Accuracy of needle placement as indicated by the lateral distance from a target
1 secondary outcome
Self-reported subjective measurements
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter Related Complication, run by Becton, Dickinson and Company at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insertion Success (time frame: 1 hour). The study lists 5 primary outcomes in all. 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 23 Mar 2021.