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Comparing Use of the Glidescope Cobalt to Direct Laryngoscopy in Infants
This study has been completed.
Sponsor:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01163656
First received: July 13, 2010
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
| Condition | Intervention |
|---|---|
| Intubation | Device: Miller Laryngoscope Device: Glidescope Cobalt Video Laryngoscopes |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Comparison of the Glidescope Cobalt to Standard Direct Laryngoscopy in Infants |
Further study details as provided by Children's Hospital of Philadelphia:
Primary Outcome Measures:
- Time to Tracheal Intubation [ Time Frame: Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation. ]The amount of time it takes the anesthesiologist to insert a breathing tube using one of two methods, either by direct laryngoscopy or using the Glidescope Cobalt Video system.
| Enrollment: | 66 |
| Study Start Date: | July 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Direct Laryngoscopy
Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope.
|
Device: Miller Laryngoscope
Device is used to facilitate tracheal intubation.
Other Names:
|
|
Active Comparator: Glidescope Cobalt Video Laryngoscopy
Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope.
|
Device: Glidescope Cobalt Video Laryngoscopes
The laryngoscope design with the integration of video technology into the laryngoscope blade.
Other Names:
|
Detailed Description:
We seek to study the intubation characteristics of a new video laryngoscope, the Glidescope Cobalt in children less than or equal to 1 yr of age. This evaluation would provide insight as to the efficacy of this device in facilitating intubation in infants.
Eligibility| Ages Eligible for Study: | up to 1 Year (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Scheduled to undergo elective surgery at CHOP
- American Society of Anesthesiologists (ASA) Physical Status I or II
- Anesthetic plan requiring tracheal intubation with a neuromuscular relaxant
- Parental/guardian permission (informed consent). Subjects will be too young to understand the study procedures and therefore assent will not be sought. -
Exclusion Criteria:
- At known or anticipated high risk for aspiration pneumonia
- Known or predicted difficult intubation as assessed by the clinical attending anesthesiologist
- Emergency surgical procedure
- Patients with preoperative airway pathology or stridor -
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01163656
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163656
Locations
| United States, Pennsylvania | |
| The Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
| Principal Investigator: | John Fiadjoe, MD | Children's Hospital of Philadelphia |
More Information
| Responsible Party: | Children's Hospital of Philadelphia |
| ClinicalTrials.gov Identifier: | NCT01163656 History of Changes |
| Other Study ID Numbers: |
10-007533 |
| Study First Received: | July 13, 2010 |
| Results First Received: | December 13, 2012 |
| Last Updated: | January 24, 2013 |
Keywords provided by Children's Hospital of Philadelphia:
|
Neonate Laryngoscopes |
Additional relevant MeSH terms:
|
Cobalt Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 26, 2017