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The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu King Vision Video Laryngoscope aBlade System | Experimental | The trachea will be intubated using the Ambu King Vision Video Laryngoscope with the appropriate sized blade (size 1 or 2) based on manufacturer guidelines and clinical judgement. |
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| Direct Laryngoscope | Active Comparator | The trachea will be intubated via direct laryngoscopy using a traditional straight blade laryngoscope, with appropriately sized blade based on manufacturer guidelines and clinical judgement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu King Vision Video Laryngoscope aBlade | Device | At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| First Attempt Success Rate of Tracheal Intubation | An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway. | Assessed intraoperatively at time of intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Grades of Laryngeal View | Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope. | Assessed intraoperatively at time of intubation |
| Time to Successful Intubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Narasimhan Jagannathan, MD | Contact | 312275170 | njagannathan@luriechildrens.org | |
| John Hajduk | Contact | 3122275295 | jhajduk@luriechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| narasimhan jagannathan, MD | Ann & Robert Lurie Children's Hospital of Chicago | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20674088 | Background | Levitan RM, Heitz JW, Sweeney M, Cooper RM. The complexities of tracheal intubation with direct laryngoscopy and alternative intubation devices. Ann Emerg Med. 2011 Mar;57(3):240-7. doi: 10.1016/j.annemergmed.2010.05.035. Epub 2010 Jul 31. | |
| 23556410 | Background | Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94. |
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| Direct Laryngoscopy via Miller Straight Blade | Device | At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed. |
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The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt.
| Assessed intraoperatively at time of intubation |
| Intraoperative Complications | Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured. | Assessed intraoperatively for the duration of the surgery |
| Postoperative Complications | Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be measured during the post-operative period. | Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour. |
| Ease of Endotracheal Tube Passage | The ease of tracheal tube passage will be measured following tracheal intubation. | Assessed intraoperatively at time of intubation |
| 24742495 | Background | Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16. |
| 23812581 | Background | Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30. |