NCT02937337

Brief Summary

In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

October 17, 2016

Last Update Submit

October 18, 2016

Conditions

Anesthesia; Functional

Outcome Measures

Primary Outcomes (1)

  • the time required for inserting the laryngeal mask airways

    time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds

Secondary Outcomes (1)

  • the numbers of insertion attempt

    interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds

Study Arms (2)

Videostylet

EXPERIMENTAL

Laryngeal mask airway insertion using video stylet guided technique

Device: Laryngeal mask insertion with videostylet guided technique

Blind

ACTIVE COMPARATOR

Laryngeal mask insertion using standard index finger-guided technique

Device: Laryngeal mask insertion with standard blind technique

Interventions

Laryngeal mask insertion with videostylet guided techniqueDEVICE
Videostylet
Laryngeal mask insertion with standard blind techniqueDEVICE
Blind

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients undergoing general anesthesia using laryngeal mask airways

You may not qualify if:

  • recent (within 2 weeks) upper respiratory infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Central Study Contacts

Hee-Soo Kim, professor

CONTACT

02-2072-3664

Study Design

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

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

KR(1)