NCT01616771

Brief Summary

The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct laryngoscopy in patients whose airway management are anticipated difficult (C\&L grade ≥3) by comparing the laryngoscopic view. Also, the investigators compared the effectiveness of smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight (GVLw) in the same patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

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

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 3, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

April 30, 2012

Results QC Date

November 21, 2013

Last Update Submit

November 3, 2014

Conditions

Keywords

laryngoscopes

Outcome Measures

Primary Outcomes (1)

  • The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.

    Glottis view was scored using C\&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other. We used modified C\&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized. For the statistical analysis, the modified C\&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view.

    up to 1 day of surgery

Secondary Outcomes (1)

  • The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL

    up to 1day of surgery

Study Arms (1)

glottis view assessment

OTHER

Glottis view assessment using Macintosh laryngoscope \& GVL selected by weight \& smaller sized GVL in single patient

Device: Macintosh laryngoscopeDevice: GVL selected by weightDevice: smaller sized GVL

Interventions

Glottis view assessment by direct visualization using Macintosh laryngoscope

glottis view assessment

Glottis view assessment by GVL selected by weight which is usually selected first

Also known as: GlideScope® videolaryngoscopy selected by weight
glottis view assessment

Glottis view assessment by GVL which is smaller in one size than GVL selected by age

Also known as: smaller sized GlideScope® videolaryngoscopy
glottis view assessment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients whose C\&L grade were over 3 in previous anesthetic records.

You may not qualify if:

  • Patients with pulmonary aspiration, increased intracranial pressure, and severe cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Jin-Tae Kim
Organization
Seoul National University Hospital

Study Officials

  • Jin-Tae Kim, professor

    Seoul National University Hospital

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 30, 2012

First Posted

June 12, 2012

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 4, 2014

Results First Posted

November 3, 2014

Record last verified: 2014-11