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

The Training and Evaluate Effect of Simulation on Clinical Airway Management for Novices During Perioperative Period

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.

Study Overview

• Status: Unknown
• Conditions: Airway Management; Education; Bronchoscopy
• Intervention / Treatment: Behavioral: Novice

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inconsistency of evaluation of time needed between simulate and clinical practice.	Inconsistency of time needed to navigate using bronchoscopy.	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.	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.	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.	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.	1 day, 2 days, and every continuous 7 days until 1 month after training.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efforts needed on simulate.	Hours needed to achieve well-trained.	An average of 6 hours, since begin of simulate training.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): March 6, 2019
• Primary Completion (Anticipated): May 31, 2019
• Study Completion (Anticipated): January 2, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: zs1809（novice）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No