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

NCT ID: NCT00935636

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Intubation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Peter Szmuk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Szmuk, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

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Chlidren's Medical Center Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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042009-046

Identifier Type: -

Identifier Source: org_study_id

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