Central Line ComplicationNCT01877031
Virtual Reality With Ultrasound Versus Ultrasound For Central Line Insertion
A study testing Virtual Reality and Ultrasound in people with Central Line Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Line Complication
- What is being tested?
- Virtual Reality and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jan 2014
- 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
- Age 18-80
- Require a central line inserted in the left jugular vein
- Undergoing surgery
Who cannot join
- Contraindication to left jugular vein insertion (absent vein, infection at site)
- Permanent or temporary pacemaker
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Needle Guidance With Virtual Reality Augmented Ultrasound Versus Ultrasound Guidance Alone For Central Line Insertion: A Randomized Trial.
We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.
Read the detailed description
The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.
The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.
- Conditions
- Central Line Complication
- Being tested
- Virtual Reality, Ultrasound
- Keywords
- central line, ultrasound guided central line insertion, virtual reality, augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Augmented reality
A magnetically tracked needle with an associated virtual image will be superimposed on the ultrasound image to give the user a better idea of the position of the needle.
UltrasoundDevice
Standard of Care - Ultrasound guided intervention
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Active comparator | Ultrasound only guidance of central line insertion - current standard of care. Receives: Device: Ultrasound |
| Virtual Reality | Experimental | Use of ultrasound plus virtual reality guidance to insert central line Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time taken to insert needle
Measure the time taken from needle on skin to blood in syringe
Measured: within 15 minutes
Secondary outcomes (3)
Attempts
Measure the number of attempts taken to locate the internal jugular vein. Measured by the number of times the needle is advanced.
Measured: 15 minutes
Carotid Puncture
Record if the carotid artery was hit (clinical)
Measured: within 24 hours
Pneumothorax
Monitor for pneumothorax after the procedure (clinical, Chest X-ray)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Line ComplicationStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Responsible party
- Sponsor
- Investigators
- Daniel Bainbridge, MD FRCPC, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877031
- Sponsor's protocol ID
- R-11-607
- Status last verified
- Nov 2018
- First submitted
- 9 Jun 2013
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needle Guidance With Virtual Reality Augmented Ultrasound Versus Ultrasound Guidance Alone For Central Line Insertion: A Randomized Trial.
- ClinicalTrials.gov ID
- NCT01877031
- Acronym / sponsor ID
- R-11-607
- Conditions
- Central Line Complication
- Keywords
- central line, ultrasound guided central line insertion, virtual reality, augmented reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- University of Western Ontario, Canada
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Jun 2013 (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.
We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.
Detailed description
The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.
The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Active comparator | Device: UltrasoundUltrasound only guidance of central line insertion - current standard of care. |
| Virtual Reality | Experimental | Device: Virtual RealityUse of ultrasound plus virtual reality guidance to insert central line |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- Require a central line inserted in the left jugular vein
- Undergoing surgery
Key exclusion criteria (3 listed)
- Contraindication to left jugular vein insertion (absent vein, infection at site)
- Permanent or temporary pacemaker
- Emergency surgery
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 |
|---|---|---|
| Virtual RealityAlso: Augmented realityA magnetically tracked needle with an associated virtual image will be superimposed on the ultrasound image to give the user a better idea of the position of the needle. | Device | Virtual Reality |
| UltrasoundStandard of Care - Ultrasound guided intervention | Device | Ultrasound |
Primary outcome
Time taken to insert needle
Time frame: within 15 minutes
Measure the time taken from needle on skin to blood in syringe
3 secondary outcomes
Attempts
Time frame: 15 minutes
Carotid Puncture
Time frame: within 24 hours
Pneumothorax
Time frame: 24 hours
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 6 Nov 2018.
Related trials for Central Line Complication
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
RecruitingObservational study
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
Neonatal Infection
RecruitingPhase 1
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Ovarian Cancer, HGSOC
RecruitingPhase 3
A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
Endometrial Cancer
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.
Daniel Bainbridge, MD FRCPC principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Ultrasound in people with Central Line Complication, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 3 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 6 Nov 2018. 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 Canada. 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?
Time taken to insert needle (time frame: within 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 6 Nov 2018.