A Randomized Trial Comparing the Laryngeal Mask Airway-Unique and Laryngeal Mask Airway-Supreme in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laryngeal Mask Airway in Children
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Airway Leak Pressure
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.
Detailed Description
The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). 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, and complications will also be assessed.
Investigators
Narasimhan Jagannathan
Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria
Inclusion Criteria
- •Children undergoing general anesthesia using a supraglottic airway device
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)
Outcomes
Primary Outcomes
Airway Leak Pressure
Time Frame: 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 Outcomes
- Time to secure the airway(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(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Fiberoptic grade of laryngeal view(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Gastric insufflation(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease of gastric tube placement (only in patients who receive LMA Supreme)(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Quality of the airway(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(Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours)
- Oropharyngolaryngeal morbidity at discharge(Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours)
- Oropharyngolaryngeal morbidity at 24 hours post-operatively(Measured at 24 hours after device placement/study initiation)