Procedural ComplicationNCT04235790
Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device
A study testing Eye Tracking Device in people with Procedural Complication, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Procedural Complication
- What is being tested?
- Eye Tracking Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 18 Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Novice and expert Invasive bedside procedure (IBP) teachers from Pulmonary Critical Care Medicine and Anesthesia-Critical Care at Mayo Clinic Rochester
- Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences
- Novice teachers will include those that have performed less than 50 CVCs
- Medical student or resident
Who cannot join
- <25% FTE in the ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device: Towards Improving Supervisor Expertise and Decreasing Complications in the Intensive Care Unit
Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU).
- Conditions
- Procedural Complication
- Being tested
- Eye Tracking Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Tracking DeviceDevice
Also called Tobii Pro Glasses 2.0
Eye tracking glasses
| Study group | Role | What they receive |
|---|---|---|
| Medical Student or Resident | No intervention | Subjects will perform simulated central venous catheters (CVC) insertions. |
| Novice and Expert IBP Teachers | Other | Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences. Novice teachers will include those that have performed less than 50 CVCs. Teachers will supervise 3 simulated central venous catheters (CVC) insertions with increased complexity while wearing an eye tracking device. Receives: Device: Eye Tracking Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation Frequency
Number of fixations within an area of interest. Higher values indicate focused attention.
Measured: Duration of procedure (approximately 4 hours)
Visit Frequency
Number of times an area of interest is entered and left. Indexes which areas repeatedly attracted participant's attention.
Measured: Duration of procedure (approximately 4 hours)
Dwell Time
Total fixation duration measured in seconds
Measured: Duration of procedure (approximately 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start30 Oct 2020
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural ComplicationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana J. Kelm, Mayo Clinic
- Investigators
- Diana Kelm, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235790
- Sponsor's protocol ID
- 19-003774
- Status last verified
- Aug 2021
- First submitted
- 17 Jan 2020
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device: Towards Improving Supervisor Expertise and Decreasing Complications in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04235790
- Acronym / sponsor ID
- 19-003774
- Conditions
- Procedural Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 22 Jan 2020 (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.
Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Student or Resident | No intervention | –Subjects will perform simulated central venous catheters (CVC) insertions. |
| Novice and Expert IBP Teachers | Other | Device: Eye Tracking DeviceExpert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences. Novice teachers will include those that have performed less than 50 CVCs. Teachers will supervise 3 simulated central venous catheters (CVC) insertions with increased complexity while wearing an eye tracking device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Novice and expert Invasive bedside procedure (IBP) teachers from Pulmonary Critical Care Medicine and Anesthesia-Critical Care at Mayo Clinic Rochester
- Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences
- Novice teachers will include those that have performed less than 50 CVCs
- Medical student or resident
Key exclusion criteria (1 listed)
- <25% FTE in the ICU
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 |
|---|---|---|
| Eye Tracking DeviceAlso: Tobii Pro Glasses 2.0Eye tracking glasses | Device | Novice and Expert IBP Teachers |
Primary outcome
Fixation Frequency
Time frame: Duration of procedure (approximately 4 hours)
Number of fixations within an area of interest. Higher values indicate focused attention.
Visit Frequency
Time frame: Duration of procedure (approximately 4 hours)
Number of times an area of interest is entered and left. Indexes which areas repeatedly attracted participant's attention.
Dwell Time
Time frame: Duration of procedure (approximately 4 hours)
Total fixation duration measured in seconds
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 20 Aug 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Diana Kelm, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Tracking Device in people with Procedural Complication, run by Mayo Clinic 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 4 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 20 Aug 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?
Fixation Frequency (time frame: Duration of procedure (approximately 4 hours)). The study lists 3 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 20 Aug 2021.