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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Szmuk, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00935636
First received: July 2, 2009
Last updated: June 19, 2013
Last verified: June 2013

July 2, 2009
June 19, 2013
May 2009
September 2011   (final data collection date for primary outcome measure)
Time to intubation [ Time Frame: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00935636 on ClinicalTrials.gov Archive Site
The time to laryngoscopic views, number of attempts, and the success rate [ Time Frame: from the time the device enters the mouth until the best view is acknowledged. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Neonates and infants requiring endotracheal intubation under 10 kilograms and in which the attending anesthesiologist decided to use the CGS-CVB will be included in this observational study.

Intubation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935636
042009-046
No
Peter Szmuk, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Peter Szmuk, MD UT Southwestern
University of Texas Southwestern Medical Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP