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A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children

NCT ID: NCT01633073

Last Updated: 2012-10-02

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

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.

Detailed Description

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The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. 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 during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) will also be assessed.

Conditions

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Laryngeal Masks in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LMA Supreme

Group Type ACTIVE_COMPARATOR

LMA Supreme: control device

Intervention Type DEVICE

LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.

i-gel

Group Type ACTIVE_COMPARATOR

i-gel: comparison device

Intervention Type DEVICE

i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.

Interventions

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LMA Supreme: control device

LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.

Intervention Type DEVICE

i-gel: comparison device

i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.

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 5-50 kg
* age 3 months-11 years

Exclusion Criteria

* ASA class IV, V Emergency procedures
* active respiratory infection
* known history of difficult mask ventilation
* a diagnosis of a congenital syndrome associated with difficult airway management
* airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
* active gastrointestinal reflux
* coagulopathy
* clinically significant pulmonary disease(s)
Minimum Eligible Age

3 Months

Maximum Eligible Age

11 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

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.

Reference Type BACKGROUND
PMID: 22420717 (View on PubMed)

Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.

Reference Type BACKGROUND
PMID: 22416790 (View on PubMed)

Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.

Reference Type BACKGROUND
PMID: 22070630 (View on PubMed)

Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.

Reference Type BACKGROUND
PMID: 22352745 (View on PubMed)

Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.

Reference Type BACKGROUND
PMID: 22151106 (View on PubMed)

Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.

Reference Type BACKGROUND
PMID: 21883132 (View on PubMed)

Other Identifiers

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SLMA vs i-gel

Identifier Type: -

Identifier Source: org_study_id