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| Name | Class |
|---|---|
| King Systems Corporation | INDUSTRY |
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There are several advantages of video laryngoscopy; especially their ability to provide superior glottis visualization, as compared to traditional laryngoscopy.1-3 The purpose of this three arm study was to compare the safety and efficacy of the King Vision® Video Intubation Systems (AMBU-King Systems, Denmark) to the Cobalt GlideScope® (Verathon Medical Inc., USA) in patients with anticipated difficult airways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glidescope AVL | Experimental |
| |
| King Vision Channeled VL | Experimental |
| |
| King Vision Non-Channeled (Standard) VL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video laryngoscopes | Device | Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL | During laryngoscopy and endotracheal tube placement |
| Measure | Description | Time Frame |
|---|---|---|
| First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL | During laryngoscopy and endotracheal tube placement |
| Measure | Description | Time Frame |
|---|---|---|
| Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | Total time for placing the endotracheal tube (ETT) through the vocal cords | During laryngoscopy and endotracheal tube placement |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin A Hagberg, MD | M.D. Anderson Cancer Center | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Hagberg CA, Iannucci D, Goodrich A. A comparison of the glottic view obtained with the Macintosh Video Laryngoscope in anesthetized, paralyzed, apneic patients. Direct view vs video monitor. Anesthesiology 2003; 103: A1501. | ||
| Background | Hagberg C, Matuszczak M, Ellis S, et al. A randomized comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in obese patients. Anesthesiology 2005; 103: A1420. | ||
| Background | Hagberg C, Vogt-Harenkamp C, Bogomolny Y, et al. A comparison of laryngoscopy techniques using the video laryngoscope and the traditional Macintosh laryngoscope in potentially difficult to intubate patients. Anesth Analg 2005; 100: S-212. |
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Patients were enrolled from the adult surgical operating rooms of 2 academic hospitals, Lyndon Baines Johnson General Hospital and Memorial Hermann Hospital - Texas Medical Center, in Houston, TX from August 2013 to December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glidescope AVL | Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL. |
| FG001 | King Vision Channeled VL | Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL. |
| FG002 | King Vision Non-Channeled (Standard) VL | Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glidescope AVL | Group A: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group A (N= 75) were intubated utilizing the GlideScope® AVL. |
| BG001 | King Vision Channeled VL |
| 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 | Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL | Posted | Count of Participants | Participants | During laryngoscopy and endotracheal tube placement |
|
Postoperatively in the PACU
(Other Adverse Events) Group A: 3 participants excluded due to protocol deviations, 8 participants lost to follow up.
Group B: 8 participants excluded due to protocol deviations, 2 participant lost to follow up.
Group C: 2 participants excluded due to protocol deviations, 3 participant lost to follow up.
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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 | Glidescope AVL | Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hoarseness | General disorders | Systematic Assessment | Hoarseness in voice postoperatively |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M. Gendel | The University of Texas Health Science Center at Houston (UTHealth) | +1 (713) 500-3587 | Elizabeth.M.Gendel@uth.tmc.edu |
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|
Group B: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group B (N= 75) were intubated utilizing the King Vision Channeled VL. |
| BG002 | King Vision Non-Channeled (Standard) VL | Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height (in) | Mean | Standard Deviation | inches |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| BMI (kg/m2) | Mean | Standard Deviation | kilogram per meter square |
|
| Neck Circumference (cm) | Mean | Standard Deviation | centimeters |
|
| Interincisor distance (cm) | Mean | Standard Deviation | centimeters |
|
| Thyromental distance (cm) | Mean | Standard Deviation | centimeters |
|
| Sternomental distance (cm) | Mean | Standard Deviation | centimeters |
|
| OG002 | King Vision Non-Channeled (Standard) VL | Group C: Patients were randomized into one of the three groups through a computer-generated randomization schedule. Patients in group C (N=75) were intubated utilizing the King Vision Video Laryngoscope with Standard (Non-Channeled) Blade. |
|
|
| Secondary | First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL | Posted | Count of Participants | Participants | During laryngoscopy and endotracheal tube placement |
|
|
|
| Other Pre-specified | Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL | Total time for placing the endotracheal tube (ETT) through the vocal cords | Group A: 3 participants excluded due to protocol deviations. Group B: 8 participants excluded due to protocol deviations, 2 participant had failed intubation, 4 participants had device failure. Group C: 2 participants excluded due to protocol deviations, 1 participant had device failure. | Posted | Mean | Standard Deviation | seconds | During laryngoscopy and endotracheal tube placement |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 26 |
| 64 |
| EG001 | King Vision Channeled VL | Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT. | 0 | 75 | 0 | 75 | 23 | 65 |
| EG002 | King Vision Non-Channeled (Standard) VL | Video laryngoscopes: Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT. | 0 | 75 | 0 | 75 | 22 | 70 |
| Sore Mouth | General disorders | Systematic Assessment | Sore Mouth postoperatively |
|
| Sore neck | General disorders | Systematic Assessment | Sore neck postoperatively |
|
| Sore jaw | General disorders | Systematic Assessment | Sore jaw postoperatively |
|
| Dysphonia | General disorders | Systematic Assessment | Dysphonia postoperatively |
|
| Dysphagia | General disorders | Systematic Assessment | Dysphagia postoperatively |
|
| Alteration of tongue | General disorders | Systematic Assessment | Alteration of tongue postoperatively |
|
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