Clinical trial NCT01409785: A Comparison of the LMA Unique and LMA Supreme in Children
Official title: A Prospective, Randomized Comparison of the LMA Unique and LMA Supreme in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children
Keywords: supraglottic airway devices in children
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children weighing 10 to 25 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

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Detailed description: The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique.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

Eligibility criteria: 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

Primary outcomes:
measure: Airway leak pressure
timeFrame: after placement of the supraglottic airway device/ Participants will be followed 24 hours postoperatively
Secondary outcomes:
measure: Fiberoptic grade of laryngeal view
timeFrame: After placement of the supraglottic device
measure: Adverse effects
timeFrame: Participants will be followed 24 hours postoperatively
measure: Time to secure the airway
timeFrame: after placement of the supraglottic airway device
measure: Number of attempts to place the device
timeFrame: at the beginning of anesthesia
measure: Fiberoptic view through the gastric tube
timeFrame: After placement of the LMA supreme
measure: Ease of gastric tube placement
timeFrame: After placement of the LMA supreme
measure: Gastric insufflation
timeFrame: During leak pressure testing
measure: Quality of the airway
timeFrame: During maintenance of anesthesia
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Childrens Memorial Hospital
state: Illinois
Study officials:
affiliation: childrens memorial hospital
name: narasimhan jagannathan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.