Evaluation of a Flexible Videoscope Training Simulator

Evaluation of a Flexible Videoscope Training Simulator: a Randomized, Controlled, Simulation Teaching Study

Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.

Study Overview

• Status: Completed
• Conditions: Difficult Airway
• Intervention / Treatment: Device: New training simulator; Device: Traditional simulator

Detailed Description

In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Department of Anesthesiology, Tongji Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Resident or Medical student
• Willing to participate to the study
• Consent to evaluate the measured data

Exclusion Criteria:

• experienced anesthetists

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New training simulator; Participants received training with new simulator	Device: New training simulator; Participants receive training with new simulator
Active Comparator: Traditional method; Participants received traditional training	Device: Traditional simulator; Participants receive traditional training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insertion time	time when participants perform flexible videoscope from incisor to carina	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	the rate of participants used flexible videoscope to view carina successfully	1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire	A questionnaire was used to measure the self-evaluation of the trained persons	1 hour

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Wenlong Yao, MD, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 2, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: intubation; difficult airway; flexible bronchoscope
• Other Study ID Numbers: TJMZK220405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No