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

A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children

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.

Study Overview

• Status: Completed
• Conditions: Children
• Intervention / Treatment: Device: LMA Proseal: control device; Device: LMA Supreme: comparison device

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 Type: Observational
• Enrollment (Actual): 60

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: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children weighing 10 to 20 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 10-20 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LMA Supreme	Device: LMA Supreme: comparison device; LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization; Other Names: laryngeal mask airway
LMA proseal	Device: LMA Proseal: control device; LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization; Other Names: laryngeal mask airway

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.	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to secure the airway	From picking up the airway device to bilateral chest expansion and presence of ETCO2	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	number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Fiberoptic grade of laryngeal view	The laryngeal alignment through the devices will be graded using an established scoring system	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Gastric insufflation	The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease of gastric tube placement	The ease of gastric placement will be timed and assessed using a subjective scale	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
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	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
feasibility of positive pressure ventilation	Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Quality of the airway	The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale	participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Adverse effects	complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded	Participants will be followed for the duration of anesthesia and 24 hours postoperatively

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• Trevisanuto D, Parotto M, Doglioni N, Ori C, Zanardo V, Micaglio M. The Supreme Laryngeal Mask Airway (LMA): a new neonatal supraglottic device: comparison with Classic and ProSeal LMA in a manikin. Resuscitation. 2012 Jan;83(1):97-100. doi: 10.1016/j.resuscitation.2011.07.032. Epub 2011 Aug 11.
• Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: October 4, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (ESTIMATE): October 10, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 12, 2011
• Last Update Submitted That Met QC Criteria: December 9, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: PLMA vs SLMA