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The investigators seek to prospectively compare intubation with the Glidescope Cobalt to Direct Laryngoscopy (DL) in infants.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct Laryngoscopy | Active Comparator | Laryngoscopy will be performed with the randomized device, which will be the Miller Laryngoscope. |
|
| Glidescope Cobalt Video Laryngoscopy | Active Comparator | Laryngoscopy will be performed with the randomized device, which will be the Glidescope Cobalt Video Laryngoscope. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miller Laryngoscope | Device | Device is used to facilitate tracheal intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tracheal 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. | Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Fiadjoe, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Any subject was excluded from participation if they were known or suspected to be a difficult intubation or if they required a rapid-sequence intubation.
Healthy infants under the age of 12 months undergoing elective surgery requiring tracheal intubation were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Direct Laryngoscopy Approach | Subjects were randomly assigned to an arm. |
| FG001 | Glidescope Videoscope Approach | Subjects were randomly assigned to an arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Direct Laryngoscopy Approach | Subjects were randomly assigned to an arm. |
| BG001 | Glidescope Videoscope Approach | Subjects were randomly assigned to an arm. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Tracheal 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. | Posted | Median | 95% Confidence Interval | seconds | Measured the time of the randomized device past the teeth/gums until its removal after intubation as the time to intubation. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Direct Laryngoscopy Approach | Subjects were randomly assigned to an arm. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Fiadjoe, MD | The Children's Hospital of Philadelphia | 215-590-3916 | fiadjoej@email.chop.edu |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D007828 | Laryngoscopy |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Glidescope Cobalt Video Laryngoscopes | Device | The laryngoscope design with the integration of video technology into the laryngoscope blade. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Glidescope Videoscope Approach | Subjects were randomly assigned to an arm. | 0 | 0 | 0 | 0 |
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| D003948 |
| Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013517 | Otorhinolaryngologic Surgical Procedures |