NCT04457414

Brief Summary

Cannot-intubate cannot-ventilate situations in healthy children are uncommon but are often associated with poor outcome. We studied the learning curves of inexperienced trainees for identifying cricothyroid membrane with ultrasound in pediatric patients. After watching an instructional video, 30 trainees performed 5 cricothyroid membrane identification on pediatric patients undergoing general anesthesia. We analysed their learning curves relative to performance time and ultrasound anatomy of cricothyroid membrane and relative structures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

June 30, 2020

Last Update Submit

February 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance time for identifying cricothyroid membrane with ultrasound

    from immediately after anesthetic induction to end of surgery

Secondary Outcomes (1)

  • ultrasound anatomy of cricothyroid membrane

    from immediately after anesthetic induction to end of surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients undergoing general anesthesia

You may qualify if:

  • pediatric patients undergoing general anesthesia

You may not qualify if:

  • previous history of tracheostomy
  • previous history of operation on neck

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

June 30, 2020

Primary Completion

February 5, 2021

Study Completion

February 5, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations