Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants

Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163656
• Other study ID #: 10-007533
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: January 24, 2013
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intubation

Intervention

Device:
• Miller Laryngoscope
Device is used to facilitate tracheal intubation.
• Glidescope Cobalt Video Laryngoscopes
The laryngoscope design with the integration of video technology into the laryngoscope blade.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tracheal 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.	Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation.	No