NCT04745936

Brief Summary

The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

February 4, 2021

Last Update Submit

May 30, 2022

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • Tube handling time

    From glottis visualization to completion of tracheal intubation

    during procedure

Secondary Outcomes (7)

  • Total intubation time

    during procedure

  • Time to reaching glottis

    during procedure

  • The location of the initial tube tip

    during procedure

  • Successful tracheal intubation

    during procedure, within 30 sec

  • Additional manipulation of stylet angle

    during procedure

  • +2 more secondary outcomes

Study Arms (2)

C-curve group (group C)

EXPERIMENTAL

In group C, stylet curvature is made similar to the natural curvature of endotracheal tube.

Other: Style curve similar to natural curvature of endotracheal tube

Hockey stick curve group (group H)

ACTIVE COMPARATOR

In group H, stylet curvature is made similar to hockey stick shape.

Other: Style curve similar to hockey stick shape

Interventions

Style curve similar to natural curvature of endotracheal tubeOTHER

Stylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope.

C-curve group (group C)
Style curve similar to hockey stick shapeOTHER

Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.

Hockey stick curve group (group H)

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ① Infants under 1 year old scheduled for elective surgery under general anesthesia
  • ② American Society of Anesthesiology physical status I, II

You may not qualify if:

  • Any pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

March 3, 2021

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

KR(1)