A Comparison of the LMA Unique and LMA Supreme in Children

Completed

• Conditions: Children

• Registration Number: NCT01409785
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

The goal of this study is to compare the LMA Unique and LMA Supreme in children having surgery. We hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.

Detailed Description

The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique. Both models are approved for use by the FDA, and are routinely used for airway management during general anesthesia. Three main features distinguish the laryngeal mask airway Supreme from the original LMA: i) a curved rigid airway tube, ii) provision for a gastric drain tube, and iii) a larger mask for improved fit and airway seal.

The aim of this randomized prospective study is to compare two types of the laryngeal mask airway: the laryngeal mask airway Unique and the laryngeal mask airway Supreme, in pediatric patients without the use of neuromuscular blockade. Based on the design features listed above, we hypothesize that the airway leak pressures with the LMA Supreme will be superior to the LMA Unique. 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 (airway related, gastric insufflation, trauma) will also be assessed.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children undergoing general anesthesia using a supraglottic airway device
• weight 10-25kg
• 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	after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively	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
Quality of the airway	During maintenance of anesthesia	The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale
Fiberoptic grade of laryngeal view	After placement of the supraglottic device	The laryngeal alignment through the devices will be graded using an established scoring system
Adverse effects	Participants will be followed 24 hours postoperatively	complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded
Time to secure the airway	after placement of the supraglottic airway device	From picking up the airway device to bilateral chest expansion and presence of ETCO2
Number of attempts to place the device	at the beginning of anesthesia	number of attempts needed for successful placement will be recorde (maximum of 3 attempts will be considered as a failure)
Fiberoptic view through the gastric tube	After placement of the LMA supreme	The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system
Ease of gastric tube placement	After placement of the LMA supreme	The ease of gastric placement will be assessed using a subjective scale
Gastric insufflation	During leak pressure testing	The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation

Trial Locations

Locations (1)

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