Tracheal Intubation in Children
Conditions
Keywords
laryngeal mask airway, children, tracheal intubation, fiberoptic bronchoscopy
Brief summary
The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.
Detailed description
The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.
Interventions
DEVICEAmbu Aura-i size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
DEVICEair-Q ILA size 1.5
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
DEVICEAmbu Aura-i size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
DEVICEair-Q ILA size 2
Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
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 * Weight 5-20 kg * Age one month-six years
Exclusion criteria
* ASA class IV, V Emergency procedures * History of a difficult airway * Active upper respiratory tract infection * Children receiving emergent surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease and time to successful tracheal intubation | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts to place the supraglottic device and tracheal tube | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | number of attempts needed for successful placement will be recorded (maximum of 3 attempts; \>3 attempts will be considered as a failure) |
| Airway Leak Pressure | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely |
| Fiberoptic grade of laryngeal view | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The laryngeal alignment through the devices will be graded using an established scoring system |
| Ease and time to place airway | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | From picking up the airway device to bilateral chest expansion and presence of ETCO2 |
| 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 various airway maneuvers such as jaw thrust, neck extension, advancement/ withdrawal of the supraglottic device, and/ or anterior Laryngeal Pressure to optimize tracheal intubation will be recorded |
| Adverse effects | Participants will be followed for the duration of anesthesia and 24 hours postoperatively | complications such as oxygen desaturations, inadvertent extubation, tracheal pilot balloon breakage, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded |
| Time to remove device | participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | removal will be done with the use of a removal stylet. Should inadvertent extubation occur during removal of the device, the intubation will be deemed a failure. |
Countries
United States
Outcome results
None listed