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

Completed

• Conditions: Intubation

• Registration Number: NCT00935636
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-09
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to intubation	From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chlidren's Medical Center Dallas; 🇺🇸 Dallas, Texas, United States