A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Children
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Airway Leak Pressure
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.
Detailed Description
The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) 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
- •weight 10-20 kg
- •age 6 months-6 years
Exclusion Criteria
- •ASA class IV, V Emergency procedures
- •History of a difficult airway
- •Active gastrointestinal reflux
- •Active upper respiratory tract infection
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 completely.
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)
- feasibility of positive pressure ventilation(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease of gastric tube placement(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)
- Quality of the airway(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)
- Fiberoptic view through the gastric tube(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Adverse effects(Participants will be followed for the duration of anesthesia and 24 hours postoperatively)