Tracheal Intubation Clinical Trial
Official title:
A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children
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.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 11 Years |
Eligibility |
Inclusion Criteria: - ASA (American Society of Anesthesiologists) I-III classified patients - Patients undergoing procedure where an endotracheal tube would be normally utilized Exclusion Criteria: - Children with expected difficult airways - Coagulopathy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ann & Robert H Lurie Children's Hospital of Chicago |
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
Secondary | Time to Successful Intubation | The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt. | Assessed intraoperatively at time of intubation | No |
Secondary | Intraoperative Complications | Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured. | Assessed intraoperatively for the duration of the surgery | Yes |
Secondary | 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. | Yes |
Secondary | Ease of Endotracheal Tube Passage | The ease of tracheal tube passage will be measured following tracheal intubation. | Assessed intraoperatively at time of intubation | No |
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