Tracheal Intubation
Conditions
Keywords
Laryngoscopy, Video Laryngoscopy, Tracheal intubation
Brief summary
The purpose of this study is to determine whether there is a clinically relevant difference in first attempt success rates between the Ambu King Vision Video Laryngoscope and Direct Laryngoscopy in Children.
Detailed description
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in the rate of first attempt successful intubation between the Ambu King Vision Video Laryngoscope and direct laryngoscopy using the Miller Blade Laryngoscope. Other parameters of clinical relevance such as grade of laryngeal view, percentage of glottic opening, number of insertion attempts, time for successful tracheal intubation, and complications will also be assessed.
Interventions
DEVICEAmbu King Vision Video Laryngoscope aBlade
At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
DEVICEDirect Laryngoscopy via Miller Straight Blade
At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 11 Years
Healthy volunteers
No
Inclusion criteria
* ASA (American Society of Anesthesiologists) I-III classified patients * Patients undergoing procedure where an endotracheal tube would be normally utilized
Exclusion criteria
* Children with expected difficult airways * Coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
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. |
| Time to Successful Intubation | Assessed intraoperatively at time of intubation | The time to intubation will be measured (seconds) to measure the time to intubation of the successful attempt. |
| Intraoperative Complications | Assessed intraoperatively for the duration of the surgery | Airway/device related complications including, laryngospasm, bronchospasm, regurgitation/aspiration, oxygen desaturation, will be measured. |
| Postoperative Complications | Outcome measure will be assessed postoperatively in the immediate phase 1 recovery unit for an average of 1 hour. | Airway/device related complications including sore throat, hoarseness, persistent coughing, stridor, and others will be measured during the post-operative period. |
| Ease of Endotracheal Tube Passage | Assessed intraoperatively at time of intubation | The ease of tracheal tube passage will be measured following tracheal intubation. |
Contacts
Primary ContactNarasimhan Jagannathan, MD
Backup ContactJohn Hajduk
Outcome results
None listed