KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

Tracheal Intubation Clinical Trial

Official title:

A Clinical Evaluation of the King Vision Video Laryngoscope aBlade System in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590237
• Other study ID #: 2015-304
• Status: Completed
• Phase: N/A
• First received: October 27, 2015
• Last updated: September 29, 2016
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• 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 the Ambu KingVision videolaryngoscope performs as well as direct laryngoscopy for intubating small children and infants.

Description:

The goal of this prospective randomized study is to compare the Ambu KingVision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope.

The primary outcome of the study will be time to successful intubation. Other outcomes of clinical relevance such as first attempt success rates of intubation, grade of laryngeal view, percentage of glottic opening, number of insertion attempts, hemodynamic responses, and complications will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Patients at Lurie Children's Hospital undergoing surgery/procedure where intubation is indicated

• American Society of Anesthesiology Class I-III patients

Exclusion Criteria:

• Children with an expected difficult airway

• A bleeding or blood clotting disorder

Study Design

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

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• Ambu KingVision Video Laryngoscope aBlade
At time of tracheal intubation, the subject will be intubated using the Ambu KingVision Video Laryngoscope with a size 1 aBlade. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.
• Miller Direct Laryngoscopy
At time of tracheal intubation, the subject will be intubated using a Miller blade laryngoscope. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

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	Time to Intubation	Three timepoints will be recorded, beginning with insertion of the device past the lips into the mouth. These will include time to optimal glottic view, time to removal of device from mouth, and time to first CO2 capnography upstroke. The primary outcome measure will be total time to intubation, as the sum of all three timepoints.	Assessed intraoperatively at time of intubation	No
Secondary	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	Intubation Adjustments & Ease of Use	Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.	Assessed intraoperatively following intubation	No
Secondary	Hemodynamic Parameters - Heart Rate	Heart rate (beats per minute) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.	Assessed intraoperatively at time of and following intubation	No
Secondary	Hemodynamic Parameters - Blood Pressure	Blood pressure (mmHg) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.	Assessed intraoperatively at time of and following intubation	No
Secondary	Intraoperative Complications	Airway/device related complications including, laryngospasm, bronchospasm, oxygen desaturation, will be assessed at intubation, during the surgery, and after extubation while under the anesthesiologists care.	Assessed intraoperatively	Yes
Secondary	Postoperative Complications	Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be assessed in the post anesthesia care unit.	Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery	Yes