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Closed due to low enrollment
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The investigators plan to conduct a randomized trial comparing the intubation success rate and time of the King Vision Video Laryngoscope to the Glidescope video laryngoscope in order to demonstrate the comparability of the devices.
Both the King Vision and Glidescope video laryngoscopes are advanced airway devices that are relatively low cost and are designed to improve the efficiency of both routine and difficult intubation. Both systems use disposable blades, which eliminates the need for blade sterilization and may minimize the risk of infectious exposure to patients and improve cost and efficiency associated with the sterilization processing of non-disposable laryngoscopes. The Glidescope has been commercially available longer than the King Vision, and has been more frequently studied.
Although similar in many respects, the King Vision and Glidescope systems have differing designs which may result in differences in speed and success in the management of routine and/or difficult airways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| King Vision Video Laryngoscope | Active Comparator | The patient would be randomized to intubation via use of the King Vision VL |
|
| Glidescope Video Laryngoscope | Active Comparator | The patient would be randomized to intubation via use of the Glidescope VL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| King Vision Video Laryngoscope | Device | Intubation via King Vision Video Laryngoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Until Intubation With Each Device | time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture | <100 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pulse Oximetry Saturation Value Reading During Intubation | <100 seconds | |
| Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Notation of any injury to lips, teeth, soft tissue. | during and immediately after procedure (approx 180 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Hester, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | King Vision Video Laryngoscope | The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope |
| FG001 | Glidescope Video Laryngoscope | The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | King Vision Video Laryngoscope | The patient would be randomized to intubation via use of the King Vision VL then Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope |
| BG001 |
| 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 Until Intubation With Each Device | time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture | Posted | Mean | Full Range | seconds | <100 seconds |
|
approximately 180 minutes
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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 | King Vision Video Laryngoscope | The patient would be randomized to intubation via use of the King Vision VL or Glidescope VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lip Trauma | Injury, poisoning and procedural complications | Systematic Assessment | minor lacerations associated with intubation procedure |
Study terminated early due to clinical equipoise
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doug Hester | Vanderbilt University Medical Center | 6153439419 | doug.hester@vanderbilt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2013 | May 14, 2018 | Prot_SAP_000.pdf |
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| Glidescope Video Laryngoscope | Device | Intubation via Glidescope Video Laryngoscope |
|
|
| <100 seconds |
| Glidescope Video Laryngoscope |
The patient would be randomized to intubation via use of the Glidescope VL then King Vision VL King Vision Video Laryngoscope: Intubation via King Vision Video Laryngoscope Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Pulse Oximetry Saturation Value Reading During Intubation | Posted | Mean | Full Range | percentage of oxygen saturation | <100 seconds |
|
|
|
| Secondary | Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm) | Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie. | Posted | Number | assisted maneuvers | <100 seconds |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | Notation of any injury to lips, teeth, soft tissue. | Posted | Number | participants | during and immediately after procedure (approx 180 minutes) |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 2 |
| 18 |
| EG001 | Glidescope Video Laryngoscope | The patient would be randomized to intubation via use of the Glidescope VL or King Vision VL Glidescope Video Laryngoscope: Intubation via Glidescope Video Laryngoscope | 0 | 22 | 0 | 22 | 2 | 22 |
|
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| Cricoid pressure |
|
| bougie |
|
| scope manipulation |
|