NCT03856073

Brief Summary

In this self-control experiment, anesthesiologists without experiment of bronchoscopy working in anesthesiology department in Peking Union Medical College Hospital will receive a training and evaluation procedure in simulation and clinical practice about clinical airway management. The objects was (1) to investigate the improvements of manufacturing bronchoscopy in simulation and clinical practice before and after training on simulation, (2) to record the study curve and efforts trainees needed to achieve proficiency and self-confidence on simulation, (3) to record the curve of manufacturing from skilled to unskilled, (4)to evaluate if status manufacturing on simulations could reflect the ones in clinical practice.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

February 14, 2019

Last Update Submit

March 4, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change of Time needed.

    Change of time needed to navigate using bronchoscopy.

    Changes from baseline after finishing simulate training, an average of 1 month.

  • Change of modified global rating scores (GRS).

    Change of modified global rating scores (GRS) rating manufacturing skills using bronchoscopy. Total score ranges from 4 to 20 scores at 1-score intervals, higher score matches better skill. Total score is the submission of four subscales, which evaluating central view, mucosal contact, progress and orientation using bronchoscopy, ranges from 1 to 5 scores at 1-score interval, higher scores represent better outcome.

    Changes from baseline after finishing simulate training, an average of 1 month.

  • Change of Likert score.

    Change of Likert score evaluating self-confidence using bronchoscopy. Likert score ranges from 1 to 5 scores at 1-score intervals, higher score with more self-confidence.

    Changes from baseline after finishing simulate training, an average of 1 month.

Secondary Outcomes (3)

  • Inconsistency of evaluation of time needed between simulate and clinical practice.

    1 day, 2 days, and every continuous 7 days until 1 month after training.

  • Inconsistency of evaluation of modified global rating scores between simulate and clinical practice.

    1 day, 2 days, and every continuous 7 days until 1 month after training.

  • Inconsistency of evaluation of Likert socre between simulate and clinical practice.

    1 day, 2 days, and every continuous 7 days until 1 month after training.

Other Outcomes (1)

  • Efforts needed on simulate.

    An average of 6 hours, since begin of simulate training.

Study Arms (1)

Novice

EXPERIMENTAL

Anesthesiologists without experiment of manufacturing bronchoscopy.

Behavioral: Novice

Interventions

NoviceBEHAVIORAL

Using the simulate device, the novices in bronchoscopy are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.

Novice

Eligibility Criteria

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

You may qualify if:

  • An anesthesiologist who is working on anesthesia airway management;
  • During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital;
  • Have no experience of manufacturing bronchoscopy.

You may not qualify if:

  • Cannot complete pre-training assessment; or get more than 3 of modified global rating scale score.
  • Cannot complete the training course;
  • Cannot complete the post-training evaluation;
  • Clinical airway managers were not performed during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Chunhua Yu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Chunhua Yu, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 27, 2019

Study Start

March 6, 2019

Primary Completion

May 31, 2019

Study Completion

January 2, 2020

Last Updated

March 6, 2019

Record last verified: 2019-03