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Completed

NCT Number: NCT02590237

KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial

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.

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Key information

Conditions

Tracheal Intubation

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu KingVision Video Laryngoscope aBlade

Device

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

Device

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.

Primary outcomes

  1. Time to Intubation

    Time frame: 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 outcomes

  1. First Attempt Success Rate of Tracheal Intubation

    Time frame: 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.

  2. Grades of Laryngeal View

    Time frame: Assessed intraoperatively at time of intubation

    Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope

  3. Intubation Adjustments & Ease of Use

    Time frame: Assessed intraoperatively following intubation

    Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.

  4. Hemodynamic Parameters - Heart Rate

    Time frame: 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.

  5. Hemodynamic Parameters - Blood Pressure

    Time frame: 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.

  6. Intraoperative Complications

    Time frame: 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.

  7. Postoperative Complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2015
Registry last updated
Oct 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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