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A Comparison of the LMA Unique and LMA Supreme in Children

NCT ID: NCT01409785

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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

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The LMA Supreme is a newer version of the current model, the laryngeal mask airway Unique.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

Conditions

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Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LMA Supreme

No interventions assigned to this group

LMA unique

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Narasimhan Jagannathan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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narasimhan jagannathan, MD

Role: PRINCIPAL_INVESTIGATOR

childrens memorial hospital

Locations

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Childrens Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18559351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19194153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19413827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19572845 (View on PubMed)

Other Identifiers

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LMA unique vs LMA supreme

Identifier Type: -

Identifier Source: org_study_id