Laryngeal Masks in Children
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICELMA Supreme: control device
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.
DEVICEi-gel: comparison device
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.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Children undergoing general anesthesia using a supraglottic airway device * weight 5-50 kg * age 3 months-11 years
Exclusion criteria
* ASA class IV, V Emergency procedures * active respiratory infection * known history of difficult mask ventilation * a diagnosis of a congenital syndrome associated with difficult airway management * airway abnormalities (e.g., laryngomalacia, subglottic stenosis) * active gastrointestinal reflux * coagulopathy * clinically significant pulmonary disease(s)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts to place the device | 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 will be considered as a failure) |
| 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 |
| Gastric insufflation | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation |
| Ease of gastric tube placement | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The ease of gastric placement will be timed and assessed using a subjective scale |
| Time to secure the 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 |
| Quality of the airway | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale |
| Incidence of device repositioning and/or replacement | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | 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%. |
| Oropharyngolaryngeal morbidity at discharge | Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours | Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. |
| Oropharyngolaryngeal morbidity at 24 hours post-operatively | Measured at 24 hours after device placement/study initiation | Assessed by the subject's response or parents subjective assesment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort. |
| Feasibility of positive pressure ventilation | Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours | Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient |
Countries
United States
Outcome results
None listed