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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01616771
Other study ID # H-1111-037-385
Secondary ID
Status Completed
Phase N/A
First received April 30, 2012
Last updated November 3, 2014
Start date February 2011
Est. completion date January 2012

Study information

Verified date November 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

We assumed that smaller sized GVL can slide more angulated along the tongue, so the tip of a blade can be placed more anterior and cephalad. The angle of camera would be optimized by inserting the blade further with the blade tip directed toward the larynx. This optimization may be more remarkable with smaller blade because it can be inserted with rotation. Furthermore, the location and the angle of camera are different according to GVL blade size. Considering that patient with difficult airway has hypognathia and more cephalad larynx, it may be helpful with smaller sized GVL (GVLs) rather than GVL selected by weight (GVLw) for improvement of laryngoscopic view in patients with difficult airways. We hypothesized that GVLs can provide better laryngoscopic view than GVLw and DL in patient with difficult airway.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Macintosh laryngoscope
Glottis view assessment by direct visualization using Macintosh laryngoscope
GVL selected by weight
Glottis view assessment by GVL selected by weight which is usually selected first
smaller sized GVL
Glottis view assessment by GVL which is smaller in one size than GVL selected by age

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL Glottis view was scored using C&L grade by GVL selected by weight and smaller sized GVL, and compared each other.
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 1day of surgery Yes
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