A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

Completed

• Conditions: Children

• Registration Number: NCT01449656
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-09
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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
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)
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
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
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
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
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
Fiberoptic view through the gastric tube	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours	The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system
Adverse effects	Participants will be followed for the duration of anesthesia and 24 hours postoperatively	complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded

Trial Locations

Locations (1)

Childrens Memorial Hospital; 🇺🇸 Chicago, Illinois, United States