NCT05327842

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

April 6, 2022

Last Update Submit

July 11, 2022

Conditions

Difficult Airway

Keywords

intubationflexible bronchoscopedifficult airway

Outcome Measures

Primary Outcomes (1)

  • insertion time

    time when participants perform flexible videoscope from incisor to carina

    1 hour

Secondary Outcomes (1)

  • success rate

    1 hour

Other Outcomes (1)

  • Questionnaire

    1 hour

Study Arms (2)

New training simulator

EXPERIMENTAL

Participants received training with new simulator

Device: New training simulator

Traditional method

ACTIVE COMPARATOR

Participants received traditional training

Device: Traditional simulator

Interventions

New training simulatorDEVICE

Participants receive training with new simulator

New training simulator
Traditional simulatorDEVICE

Participants receive traditional training

Traditional method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • experienced anesthetists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Tongji Hospital

Wuhan, Hubei, China

Location

Related Publications (1)

  • Zhou Z, Zhang K, Zhao X, Hu Y, He Y, Wan L, Yao W. Evaluation of a 12-hole clock model for improving bronchoscopic skills in simulated normal and difficult airways among anesthesia residents: A randomized controlled study. Medicine (Baltimore). 2024 Jun 7;103(23):e38510. doi: 10.1097/MD.0000000000038510.

    PMID: 38847658DERIVED

Study Officials

  • Wenlong Yao, MD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 14, 2022

Study Start

May 15, 2022

Primary Completion

June 30, 2022

Study Completion

July 2, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)