Tracheal Intubation
Conditions
Keywords
Laryngoscopy, Video Laryngoscopy
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.
Interventions
DEVICEAmbu 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.
DEVICEMiller 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.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed