The Training and Evaluate Effect on Clinical Airway Management for Novices.

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03856073
Collaborator
(none)
150
1
9.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Novice
N/A

Detailed Description

A modified global rating scale from 1 (unskilled) to 5 (expert) with a score of 3 linked to proficiency, and 5-points Likert from 1 (felt extremely unsure) to 5 (felt extremely confidence) with a score of 4 linked to confidence were used to evaluate during the procedure of training and evaluation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Training and Evaluate Effect of Simulation on Clinical Airway Management for Novices During Perioperative Period
Anticipated Study Start Date :
Mar 6, 2019
Anticipated Primary Completion Date :
May 31, 2019
Anticipated Study Completion Date :
Jan 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Novice

Anesthesiologists without experiment of manufacturing bronchoscopy.

Behavioral: Novice
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.

Outcome Measures

Primary Outcome Measures

  1. Change of Time needed. [Changes from baseline after finishing simulate training, an average of 1 month.]

    Change of time needed to navigate using bronchoscopy.

  2. Change of modified global rating scores (GRS). [Changes from baseline after finishing simulate training, an average of 1 month.]

    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.

  3. Change of Likert score. [Changes from baseline after finishing simulate training, an average of 1 month.]

    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.

Secondary Outcome Measures

  1. 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 time needed to navigate using bronchoscopy.

  2. 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 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.

  3. 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.]

    Inconsistency 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.

Other Outcome Measures

  1. Efforts needed on simulate. [An average of 6 hours, since begin of simulate training.]

    Hours needed to achieve well-trained.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. An anesthesiologist who is working on anesthesia airway management;

  2. During the research period, he/she worked in the anesthesiology department of Peking Union Medical College Hospital;

  3. Have no experience of manufacturing bronchoscopy.

Exclusion Criteria:
  1. Cannot complete pre-training assessment; or get more than 3 of modified global rating scale score.

  2. Cannot complete the training course;

  3. Cannot complete the post-training evaluation;

  4. Clinical airway managers were not performed during the study period.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Study Chair: Chunhua Yu, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunhua Yu, Chief Physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03856073
Other Study ID Numbers:
  • zs1809(novice)
First Posted:
Feb 27, 2019
Last Update Posted:
Mar 6, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 6, 2019