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

• ClinicalTrials.gov Identifier: NCT03856073
• Recruitment Status: Unknown
• First Posted: February 27, 2019
• Last Update Posted: March 6, 2019
• Sponsor: Peking Union Medical College Hospital
• Information provided by (Responsible Party): Chunhua Yu, Peking Union Medical College Hospital

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
Airway Management; Education; Bronchoscopy	Behavioral: Novice	Not Applicable

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 (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: March 6, 2019
• Estimated Primary Completion Date: May 31, 2019
• Estimated Study Completion Date: January 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. [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: An average of 6 hours, since begin of simulate training. ]
   Hours needed to achieve well-trained.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts

Contact: Chunhua Yu, Doctor; 010-69152030; counsissis@sina.com

Contact: Yuan Tian; 18810261573; counsissis@sina.com

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

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

More Information

• Responsible Party: Chunhua Yu, Chief Physician, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03856073
• Other Study ID Numbers: zs1809（novice）
• First Posted: February 27, 2019
• Last Update Posted: March 6, 2019
• Last Verified: March 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No