NCT04578119

Brief Summary

In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

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

September 23, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

September 23, 2020

Last Update Submit

May 9, 2022

Conditions

Cervical Spine SurgeryIntubation;Difficult

Outcome Measures

Primary Outcomes (1)

  • percentage of glottic opening (POGO) score (%)

    The POGO score represents the percentage of glottic opening seen, defined by the linear span from the anterior commisure to the interarytenoid notch.

    When we insert the endotracheal tube during anesthetic induction

Study Arms (2)

Conventional Intubating Technique

NO INTERVENTION

'Conventional technique' means that endotracheal intubation is performed with the videolayngoscope blade lifting up the epiglottis.

Sliding Intubating Technique

EXPERIMENTAL

'Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.

Procedure: Sliding Intubating Technique

Interventions

Sliding Intubating TechniquePROCEDURE

Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.

Sliding Intubating Technique

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Adult patients (over 19 years of age) with ASA class I-III undergoing cervical spine surgery at our institution in the department of spine neurosurgery

You may not qualify if:

  • When rapid sequence induction is required
  • When awake intubation is required
  • If a subject is on the medication for asthma
  • If as subject cannot read or understand the consent form of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 8, 2020

Study Start

October 7, 2020

Primary Completion

August 31, 2021

Study Completion

September 7, 2021

Last Updated

May 11, 2022

Record last verified: 2022-05

Locations

KR(1)