NCT04948294

Brief Summary

The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

3.3 years

First QC Date

June 26, 2021

Last Update Submit

October 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    the time for tracheal intubation

    Immediately after tracheal intubation completed

Secondary Outcomes (2)

  • First-pass rate

    Immediately after tracheal intubation completed

  • Intubation-related complications

    within 24 hours after surgery

Study Arms (2)

Channeled group

EXPERIMENTAL

Group of patients using a channeled blade for videolaryngoscopy

Device: Channeled blade

Non-channeled group

ACTIVE COMPARATOR

Group of patients using a non-channeled blade (standard type) for videolaryngoscopy

Device: Non-channeled blade

Interventions

In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation

Channeled group

In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation

Non-channeled group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving tracheal intubation for general anesthesia
  • Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.

You may not qualify if:

  • Body mass index \<18.5 kg/m2 or \>35 kg/m2
  • Patients with a history of airway surgery
  • Patients with increased risk of aspiration
  • Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Gangdong Hospital

Seoul, 05278, South Korea

Location

Study Officials

  • Hyungseok Seo, MD, PhD

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients requiring tracheal intubation for general anesthesia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 26, 2021

First Posted

July 1, 2021

Study Start

August 22, 2018

Primary Completion

December 15, 2021

Study Completion

December 31, 2021

Last Updated

October 27, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations