NCT04235790

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

January 17, 2020

Last Update Submit

August 18, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fixation Frequency

    Number of fixations within an area of interest. Higher values indicate focused attention.

    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.

    Duration of procedure (approximately 4 hours)

  • Dwell Time

    Total fixation duration measured in seconds

    Duration of procedure (approximately 4 hours)

Study Arms (2)

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.

Device: Eye Tracking Device

Interventions

Eye tracking glasses

Also known as: Tobii Pro Glasses 2.0
Novice and Expert IBP Teachers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<25% FTE in the ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Diana Kelm, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 22, 2020

Study Start

October 30, 2020

Primary Completion

August 18, 2021

Study Completion

August 18, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations