KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

Not Applicable

Completed

• Conditions: Tracheal Intubation
• Interventions: Device: Ambu KingVision Video Laryngoscope aBlade; Device: Miller Direct Laryngoscopy

• Registration Number: NCT02590237
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KingVision Video Laryngoscope	Ambu KingVision Video Laryngoscope aBlade	The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade.
Direct Laryngoscopy	Miller Direct Laryngoscopy	The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope.

Primary Outcome Measures

Name	Time	Method
Time to Intubation	Assessed intraoperatively at time of 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.

Secondary Outcome Measures

Name	Time	Method
First Attempt Success Rate of Tracheal Intubation	Assessed intraoperatively at time of 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.
Grades of Laryngeal View	Assessed intraoperatively at time of intubation	Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope
Intubation Adjustments & Ease of Use	Assessed intraoperatively following intubation	Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.
Hemodynamic Parameters - Heart Rate	Assessed intraoperatively at time of and following intubation	Heart rate (beats per minute) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.
Hemodynamic Parameters - Blood Pressure	Assessed intraoperatively at time of and following intubation	Blood pressure (mmHg) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.
Intraoperative Complications	Assessed intraoperatively	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.
Postoperative Complications	Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery	Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be assessed in the post anesthesia care unit.

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States