NCT01449656

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

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

October 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 12, 2011

Status Verified

December 1, 2011

Enrollment Period

1 month

First QC Date

October 4, 2011

Last Update Submit

December 9, 2011

Conditions

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 completely.

    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

    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 proseal

Device: LMA Proseal: control device

LMA Supreme

Device: LMA Supreme: comparison device

Interventions

LMA Proseal: control deviceDEVICE

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

Also known as: laryngeal mask airway
LMA proseal
LMA Supreme: comparison deviceDEVICE

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

Also known as: laryngeal mask airway
LMA Supreme

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device

You may qualify if:

  • Children undergoing general anesthesia using a supraglottic airway device
  • weight 10-20 kg
  • age 6 months-6 years

You may not qualify if:

  • ASA class IV, V Emergency procedures
  • History of a difficult airway
  • Active gastrointestinal reflux
  • Active upper respiratory tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Publications (3)

  • 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.

    PMID: 21839703BACKGROUND

  • 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.

    PMID: 20540172BACKGROUND

  • 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.

    PMID: 19572845BACKGROUND

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

    Childrens Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 10, 2011

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 12, 2011

Record last verified: 2011-12

Locations

US(1)