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
  Purpose

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.


Condition
Intubation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: May 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935636

Locations
United States, Texas
Chlidren's Medical Center Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Peter Szmuk, MD UT Southwestern
  More Information

No publications provided

Responsible Party: Peter Szmuk, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00935636     History of Changes
Other Study ID Numbers: 042009-046
Study First Received: July 2, 2009
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Intubation

ClinicalTrials.gov processed this record on April 16, 2014