An Evaluation of Efficacy of the GlideScope Cobalt Video Baton for Intubation on Children Weighing Less Than 10 Kilograms
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
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 |
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.
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| Contact: Peter Szmuk, MD | 214-456-6404 | peter.szmuk@utsouthwestern.edu |
| United States, Texas | |
| Chlidren's Medical Center Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Peter Szmuk, MD 214-456-6404 peter.szmuk@utsouthwestern.edu | |
| Sub-Investigator: Patrick Olomu, MD | |
| Sub-Investigator: Chris Glover, MD | |
| Sub-Investigator: Osama Aboul-Fettouh, MD | |
| Principal Investigator: | Peter Szmuk, MD | UT Southwestern |
More Information
No publications provided
| Responsible Party: | Peter Szmuk, MD, UT Southwestern Medical Center and Children's Medical Center Dallas |
| ClinicalTrials.gov Identifier: | NCT00935636 History of Changes |
| Other Study ID Numbers: | 042009-046 |
| Study First Received: | July 2, 2009 |
| Last Updated: | July 7, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Texas Southwestern Medical Center:
|
Intubation |
ClinicalTrials.gov processed this record on May 16, 2013