NCT01653795

Brief Summary

The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

4 months

First QC Date

July 27, 2012

Last Update Submit

November 17, 2012

Conditions

Laryngeal Mask Airway in Children

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Secondary Outcomes (9)

  • Time to secure the airway

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  • Number of attempts to place the device

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  • Fiberoptic grade of laryngeal view

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  • Gastric insufflation

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  • Ease of gastric tube placement (only in patients who receive LMA Supreme)

    Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

  • +4 more secondary outcomes

Study Arms (2)

LMA Unique

ACTIVE COMPARATOR
Device: LMA Unique: control device

LMA Supreme

ACTIVE COMPARATOR
Device: LMA Supreme: comparison device

Interventions

LMA Unique: control deviceDEVICE

LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. 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.

Also known as: Laryngeal Mask Airway
LMA Unique
LMA Supreme: comparison deviceDEVICE

LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, 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.

Also known as: Laryngeal Mask Airway
LMA Supreme

Eligibility Criteria

Age3 Months - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children undergoing general anesthesia using a supraglottic airway device

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

  • 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.

    PMID: 22420717BACKGROUND

  • 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.

    PMID: 22416790BACKGROUND

  • 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.

    PMID: 22070630BACKGROUND

  • 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.

    PMID: 22352745BACKGROUND

  • 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.

    PMID: 22151106BACKGROUND

  • 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.

    PMID: 21883132BACKGROUND

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Narasimhan Jagannathan, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

US(1)