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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03854760
Other study ID # zs1809
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 5, 2019
Est. completion date January 2, 2020

Study information

Verified date March 2019
Source Peking Union Medical College Hospital
Contact Chunhua Yu, Doctor
Phone 010-69152030
Email counsissis@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this self-control experiment, anesthesiologists with limited experiments 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 practise before and after training on simulation,(2) to record the efforts trainees needed to achieve experienced on simulation, (3) to evaluate if status manufacturing on simulations could reflect the ones in clinical practise.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date January 2, 2020
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 65 Years
Eligibility 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 some experience in airway management,Meet at least one of the following conditions: ?Airway management experience =10 cases;?Objective GRS score <3 points;?Subjective Likert score <3 points

Exclusion Criteria:

1. Cannot complete pre-training assessment;

2. Cannot complete the training course;

3. Cannot complete the post-training evaluation;

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
anesthesiologist with limited experiment
Using the simulate device, the trainees are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Efforts needed on simulate. Hours needed to achieve well-trained. An average of 6 hours, since begin of simulate training.
Other Efforts needed on simulate. Cases needed to achieve well-trained. An average of 6 hours, since begin of simulate training.
Primary Change of Time needed. Change of time needed to navigate using bronchoscopy. Changes from baseline after finishing simulate training, an average of 1 month.
Primary 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.
Primary 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 Inconsistency of evaluation of time needed between simulate and clinical practice. Inconsistency of time needed to navigate using bronchoscopy. At the beginning and after finishing the training, an average of 1 month.
Secondary Inconsistency of evaluation of modified global rating scores (GRS) between simulate and clinical practice. 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. At the beginning and after finishing the training, an average of 1 month.
Secondary Inconsistency of evaluation of Likert score between simulate and clinical practice. 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. At the beginning and after finishing the training, an average of 1 month.
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