An interventional study of Ambu KingVision Video Laryngoscope aBlade and Miller Direct Laryngoscopy in Tracheal Intubation, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in United States. Open to participants aged Up to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-03.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable and Interventional
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.
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.
Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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Exclusion Criteria:
The trachea will be intubated via direct laryngoscopy using a traditional straight blade (Miller) laryngoscope.
Device: Miller Direct Laryngoscopy
The trachea will be intubated using the Ambu KingVision Video Laryngoscope size 1 pediatric blade.
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.
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.
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.
Time frame: Assessed intraoperatively at time of intubation
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.
Time frame: Assessed intraoperatively at time of intubation
Grades of Laryngeal View
Cormack Lehane (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope
Time frame: Assessed intraoperatively at time of intubation
Intubation Adjustments & Ease of Use
Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.
Time frame: Assessed intraoperatively following intubation
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.
Time frame: Assessed intraoperatively at time of and following intubation
Hemodynamic Parameters - Blood Pressure
Blood pressure (mmHg) will be assessed prior to intubation and at 1 minute intervals, for 5 minutes, following intubation.
Time frame: Assessed intraoperatively at time of and following intubation
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.
Time frame: Assessed intraoperatively
Postoperative Complications
Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be assessed in the post anesthesia care unit.
Time frame: Assessed postoperatively while admitted to the phase 1 recovery unit, approximately 30-60 minutes after surgery
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago