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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449656
• Other study ID #: PLMA vs SLMA
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: December 9, 2011
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children

Intervention

Device:
• LMA Proseal: control device
LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization
• LMA Supreme: comparison device
LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization

Locations

Country	Name	City	State
United States	Childrens Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No