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

NCT ID: NCT01449656

Last Updated: 2011-12-12

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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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.

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 proseal

LMA Proseal: control device

Intervention Type DEVICE

LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization

LMA Supreme

LMA Supreme: comparison device

Intervention Type DEVICE

LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization

Interventions

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LMA Proseal: control device

LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization

Intervention Type DEVICE

LMA Supreme: comparison device

LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization

Intervention Type DEVICE

Other Intervention Names

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laryngeal mask airway laryngeal mask airway

Eligibility Criteria

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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
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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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.

Reference Type BACKGROUND
PMID: 21839703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20540172 (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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PLMA vs SLMA

Identifier Type: -

Identifier Source: org_study_id