The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
170
LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Airway Leak Pressure
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.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Time to secure the airway
From picking up the airway device to bilateral chest expansion and presence of ETCO2
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Number of attempts to place the device
Number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic grade of laryngeal view
The laryngeal alignment through the devices will be graded using an established scoring system
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Gastric insufflation
The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease of gastric tube placement
The ease of gastric placement will be timed and assessed using a subjective scale
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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Feasibility of positive pressure ventilation
Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Quality of the airway
The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Incidence of device repositioning and/or replacement
Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Oropharyngolaryngeal morbidity at discharge
Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Time frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours
Oropharyngolaryngeal morbidity at 24 hours post-operatively
Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort.
Time frame: Measured at 24 hours after device placement/study initiation