Tracheal Intubation in Children
Conditions
Keywords
supraglottic airway, children, fiberoptic guided tracheal intubation, air-Q, i-gel
Brief summary
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
Detailed description
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, time for device removal after intubation, and peri-operative complications will also be assessed.
Interventions
DEVICEi-gel
Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
DEVICEair-Q
Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Children undergoing general anesthesia requiring tracheal intubation * Age one month to six years
Exclusion criteria
* ASA class IV, V * Children receiving emergent surgery * History or high suspicion of a difficult airway * Active upper respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Successful Tracheal Intubation | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts to Place the Supraglottic Device | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Number of attempts will be limited to 3 |
| Supraglottic Airway Leak Pressure | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The airway pressure at which an airway leak is observed after placement of the supraglottic airway |
| Fiberoptic Grade of Laryngeal View | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Fiberoptic Grade of Laryngeal View through either the air Q or i-gel will be graded using a previously published grading system |
| Ease of Placement of Supraglottic Airway | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Ease of placement of supraglottic device ranging from 1 (easy) to 4 (difficult). |
| Postoperative Complications | Participants will be followed for the duration of anesthesia and 24 hours postoperatively | Complications noted postoperatively relating to the airway, such as sore throat or hoarseness. |
| Time to Placement of Supraglottic Airway | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Time to placement of supraglottic device will be measured. |
| Number of Attempts to Place the Tracheal Tube | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Number of attempts to place the tracheal tube via fiberoptic bronchoscopy through supraglottic device will be limited to 3 |
| Airway Maneuvers | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The number and type of airway maneuvers performed during tracheal intubation will be recorded |
Countries
United States
Outcome results
None listed