Operative Surgical Procedures
Conditions
Brief summary
Endotracheal intubation is the gold standard for securing the airway. However, while managing patients with difficult airways, various supraglottic devices have been used as rescue airway devices. The aim of this study is to compare the fiberoptic view through the internal aspect of the i-gel versus the Air-Q LMA in pediatric patients. By examining the fiberoptic view through these two devices, the investigators will determine which device provides a clearer passage to the glottic opening and is therefore the preferred conduit to aid endotracheal intubation in difficult airways.
Interventions
DEVICEAir-Q
DEVICEi-gel
Sponsors
Senthil G. Krishna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients less than 18 years of age who will be receiving an LMA as part of standard of care for their procedure.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable View of the Glottic Aperature (Grade I-II) | 15 seconds after insertion of Air-Q or i-gel | Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Airway Insertion Time | Immediately after anesthesia induction | Amount of time it takes to insert airway. |
| Time to Achieve Best Fiberoptic View | 15 seconds after insertion of Air-Q or i-gel | After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Air-Q The Air-Q is composed of an airway tube that connects to an elliptical mask with a cuff which is inserted through the patient's mouth, down the windpipe, and once deployed forms an airtight seal on top the glottis (unlike tracheal tubes which pass through the glottis) allowing a secure airway to be managed by a health care provider.
Air-Q | 25 |
| I-gel The i-gel is designed to create a non-inflatable anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures whilst avoiding the compression trauma that can occur with inflatable supraglottic airway devices.
i-gel | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Air-Q | Total | I-gel |
|---|---|---|---|
| Age, Continuous | 14 years | 13 years | 12 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 25 participants | 50 participants | 25 participants |
| Sex: Female, Male Female | 13 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
| Weight | 50 kilograms | 49 kilograms | 49 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Acceptable View of the Glottic Aperature (Grade I-II)
Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.
Time frame: 15 seconds after insertion of Air-Q or i-gel
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Air-Q | Acceptable View of the Glottic Aperature (Grade I-II) | 20 participants |
| I-gel | Acceptable View of the Glottic Aperature (Grade I-II) | 21 participants |
Secondary
Airway Insertion Time
Amount of time it takes to insert airway.
Time frame: Immediately after anesthesia induction
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Air-Q | Airway Insertion Time | 19 seconds |
| I-gel | Airway Insertion Time | 21 seconds |
Secondary
Time to Achieve Best Fiberoptic View
After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded.
Time frame: 15 seconds after insertion of Air-Q or i-gel
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Air-Q | Time to Achieve Best Fiberoptic View | 25 seconds |
| I-gel | Time to Achieve Best Fiberoptic View | 21 seconds |