An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 2, 2009
CompletedFirst Posted
Study publicly available on registry
July 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJune 21, 2013
June 1, 2013
2.3 years
July 2, 2009
June 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to intubation
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
from the time the device enters the mouth until the best view is acknowledged.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients at risk of pulmonary aspiration,
- Increased intracranial pressure
- Those with congenital cardiac diseases or
- Those with hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chlidren's Medical Center Dallas
Dallas, Texas, 75235, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Szmuk, MD
UT Southwestern
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 2, 2009
First Posted
July 9, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2011
Study Completion
October 1, 2011
Last Updated
June 21, 2013
Record last verified: 2013-06