King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

Tracheal Intubation Clinical Trial

Official title:

A Randomized Comparison of the King Vision Video Laryngoscope aBlade vs. Direct Laryngoscopy in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02384564
• Other study ID #: IRB 2015-304
• Status: Not yet recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: July 27, 2015
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: July 2015
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Narasimhan Jagannathan, MD
• Phone: 312275170
• Email: njagannathan[@]luriechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• Ambu King Vision Video Laryngoscope aBlade
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.
• Direct Laryngoscopy via Miller Straight Blade
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

References & Publications (4)

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

Outcome

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