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OpenTrials
Completed

NCT Number: NCT00935636

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.

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Key information

Conditions

Intubation

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chlidren's Medical Center Dallas

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time to intubation

    Time frame: From the time the ETT enters the mouth until end-tidal carbon dioxide is detected on the monitor screen

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2009
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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