A Comparison of the LMA Unique and LMA Supreme in Children

A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children

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.

Study Overview

• Status: Completed
• Conditions: Children

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The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique.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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Childrens Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children weighing 10 to 25 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LMA Supreme
LMA unique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway leak pressure	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.	after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

General Publications

• Verghese C, Ramaswamy B. LMA-Supreme--a new single-use LMA with gastric access: a report on its clinical efficacy. Br J Anaesth. 2008 Sep;101(3):405-10. doi: 10.1093/bja/aen174. Epub 2008 Jun 17.
• Timmermann A, Cremer S, Eich C, Kazmaier S, Brauer A, Graf BM, Russo SG. Prospective clinical and fiberoptic evaluation of the Supreme laryngeal mask airway. Anesthesiology. 2009 Feb;110(2):262-5. doi: 10.1097/ALN.0b013e3181942c4d.
• Cook TM, Gatward JJ, Handel J, Hardy R, Thompson C, Srivastava R, Clarke PA. Evaluation of the LMA Supreme in 100 non-paralysed patients. Anaesthesia. 2009 May;64(5):555-62. doi: 10.1111/j.1365-2044.2008.05824.x.
• White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: August 3, 2011
• First Submitted That Met QC Criteria: August 3, 2011
• First Posted (Estimate): August 4, 2011

Study Record Updates

• Last Update Posted (Estimate): October 5, 2011
• Last Update Submitted That Met QC Criteria: October 4, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: supraglottic airway devices in children
• Other Study ID Numbers: LMA unique vs LMA supreme