Trial Outcomes & Findings for Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants (NCT NCT01163656)

Last Updated: 2013-01-31

Results Overview

The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.

Results posted on

2013-01-31

Participant Flow

Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.

Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.

Participant milestones

Participant milestones
Measure	Direct Laryngoscopy Approach Subjects were randomly assigned to an arm.	Glidescope Videoscope Approach Subjects were randomly assigned to an arm.
Overall Study STARTED	33	33
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Direct Laryngoscopy Approach n=33 Participants Subjects were randomly assigned to an arm.	Glidescope Videoscope Approach n=33 Participants Subjects were randomly assigned to an arm.	Total n=66 Participants Total of all reporting groups
Age, Categorical <=18 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	0.425 years STANDARD_DEVIATION 0.275 • n=5 Participants	0.492 years STANDARD_DEVIATION 0.283 • n=7 Participants	0.459 years STANDARD_DEVIATION 0.279 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.

The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.

Outcome measures

Outcome measures
Measure	Direct Laryngoscopy Approach n=30 Participants Subjects were randomly assigned to an arm.	Glidescope Videoscope Approach n=30 Participants Subjects were randomly assigned to an arm.
Time to Tracheal Intubation	21.4 seconds Interval 9.5 to 66.1	22.6 seconds Interval 13.3 to 61.0

Adverse Events

Direct Laryngoscopy Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Glidescope Videoscope Approach

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

John Fiadjoe, MD

The Children's Hospital of Philadelphia

Phone: 215-590-3916

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place