Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Device: Miller Laryngoscope; Device: Glidescope Cobalt Video Laryngoscopes

• Registration Number: NCT01163656
• Lead Sponsor: Children's Hospital of Philadelphia

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-16
• Primary Completion: 2011-02
• Study Completion: 2012-03
• Results First Submitted: 2012-12-13
• Results First Submitted QC: 2012-12-13
• Status Verified: 2013-01
• Results First Posted: 2013-01-18
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Laryngoscopy	Miller Laryngoscope	Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.
Glidescope Cobalt Video Laryngoscopy	Glidescope Cobalt Video Laryngoscopes	Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.

Primary Outcome Measures

Name	Time	Method
Time to Tracheal Intubation	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.

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States