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Clinical Trials/NCT01163656
NCT01163656CompletedNot Applicable

A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants

Children's Hospital of Philadelphia1 site in 1 country66 target enrollmentStarted: July 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
66
Locations
1
Primary Endpoint
Time to Tracheal Intubation

Study Overview

Brief Summary

The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.

Detailed Description

We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 1 Year (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Scheduled to undergo elective surgery at CHOP
  • •American Society of Anesthesiologists (ASA) Physical Status I or II
  • •Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
  • •Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -

Exclusion Criteria

  • •At known or anticipated high risk for aspiration pneumonia
  • •Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
  • •Emergency surgical procedure
  • •Patients with preoperative airway pathology or stridor -

Arms & Interventions

Direct Laryngoscopy

Active Comparator

Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.

Intervention: Miller Laryngoscope (Device)

Glidescope Cobalt Video Laryngoscopy

Active Comparator

Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.

Intervention: Glidescope Cobalt Video Laryngoscopes (Device)

Outcomes

Primary Outcomes

Time to Tracheal Intubation

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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