A Comparison of the LMA Unique and LMA Supreme in Children

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409785
• Other study ID #: LMA unique vs LMA supreme
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: October 4, 2011
• Start date: August 2011
• Est. completion date: September 2011

Study information

• Verified date: October 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 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.

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The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: September 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 10-25kg

• 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Children

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 (4)

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. — View Citation

Timmermann A, Cremer S, Eich C, Kazmaier S, Bräuer 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. — View Citation

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. — 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.	after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively	Yes
Secondary	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	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 24 hours postoperatively	No
Secondary	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	No
Secondary	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	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	After placement of the LMA supreme	No
Secondary	Ease of gastric tube placement	The ease of gastric placement will be assessed using a subjective scale	After placement of the LMA supreme	No
Secondary	Gastric insufflation	The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation	During leak pressure testing	No
Secondary	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	No