Trial Outcomes & Findings for GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade (NCT NCT01616771)

NCT ID: NCT01616771

Last Updated: 2014-11-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

up to 1 day of surgery

Results posted on

2014-11-04

Participant Flow

Participant milestones

Participant milestones
Measure
Glottis View Assessment
After checking the C\&L grade using Macintosh laryngoscope, C\&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
Macintosh Laryngoscopy for 5 Sec
STARTED
23
Macintosh Laryngoscopy for 5 Sec
COMPLETED
23
Macintosh Laryngoscopy for 5 Sec
NOT COMPLETED
0
GVL Selected by Weight for 5 Sec
STARTED
23
GVL Selected by Weight for 5 Sec
COMPLETED
23
GVL Selected by Weight for 5 Sec
NOT COMPLETED
0
Smaller Sized GVL for 5 Sec
STARTED
23
Smaller Sized GVL for 5 Sec
COMPLETED
19
Smaller Sized GVL for 5 Sec
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Glottis View Assessment
After checking the C\&L grade using Macintosh laryngoscope, C\&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
Smaller Sized GVL for 5 Sec
lack of GVL size
4

Baseline Characteristics

GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Glottis View Assessment
n=23 Participants
After checking the C\&L grade using Macintosh laryngoscope, C\&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
Age, Categorical
<=18 years
23 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
7.9 years
STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
Sex: Female, Male
Male
13 Participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 1 day of surgery

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.

Outcome measures

Outcome measures
Measure
Macintosh Laryngoscope
n=23 Participants
After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C\&L grade was checked.
GVL Selected by Weight
n=23 Participants
Right after Macintosh laryngoscope was removed, C\&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.
6 units on a scale
Interval 5.5 to 6.0
5.5 units on a scale
Interval 5.0 to 6.0

SECONDARY outcome

Timeframe: up to 1day of surgery

Population: Four of 23 patients could not be evaluated by smaller sized GVL because there was no smaller blade than their GVL selected by weight.

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.

Outcome measures

Outcome measures
Measure
Macintosh Laryngoscope
n=23 Participants
After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C\&L grade was checked.
GVL Selected by Weight
n=19 Participants
Right after Macintosh laryngoscope was removed, C\&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL
5.5 units on a scale
Interval 5.0 to 6.0
1 units on a scale
Interval 1.0 to 1.5

Adverse Events

Macintosh Laryngoscope

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

GVL Selected by Weight

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smaller Sized GVL

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jin-Tae Kim

Seoul National University Hospital

Phone: 82-10-6260-8490

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place