An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms

Intubation Clinical Trial

Official title:

An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935636
• Other study ID #: 042009-046
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: June 19, 2013
• Start date: May 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect relevant airway data using the GlideScope Cobalt Video Baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.

Description:

Neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study. Data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet The data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study.

The decision of using the GS-CVB is at the discretion of the attending anesthesiologist. Consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. This will also require that all possible patients's should be consented which will put a serious strain on the study personal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation

• Patients age 0 - 2 years

• Weight up to 10 kg

• American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

• Patients at risk of pulmonary aspiration,

• Increased intracranial pressure

• Those with congenital cardiac diseases or

• Those with hemodynamic instability

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intubation

Locations

Country	Name	City	State
United States	Chlidren's Medical Center Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to intubation		From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen	No
Secondary	The time to laryngoscopic views, number of attempts, and the success rate		from the time the device enters the mouth until the best view is acknowledged.	No