Expired Study
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Chicago, Illinois 60618


The purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.

Study summary:

The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.


Inclusion Criteria: - Children undergoing general anesthesia using a supraglottic airway device - 3 to 9 years of age - 20 to 30 kilograms in weight Exclusion Criteria: - History of a difficult airway - Active gastrointestinal reflux - Active upper respiratory tract infection

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

Official Title:

A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children

Overall Status:


Study Phase:




Minimum Age:

3 Years

Maximum Age:

9 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Memorial Hospital

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Observational Model: Case Control, Time Perspecti

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Narasimhan Jagannathan, MD
Principal Investigator
Childrens Memorial Hospital

Study Dates

Start Date:June 2011
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 9, 2012
First Received Date:June 28, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Oropharyngeal leak pressure
Time Frame:2 months
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Laryngeal Mask Airway
Description:Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
Arm Name:Laryngeal Mask airway (LMA)
Other Name:Laryngeal Mask AirwayTM (Laryngeal Mask Airway Nor
Intervention Type:Device
Name:air-QTM Intubating Laryngeal Airway
Description:Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
Arm Name:Intubating Laryngeal Airway (ILA-SP)
Other Name:air-QTM Intubating Laryngeal Airway Mercury Medica

Study Arms

Study Arm Type:Other
Arm Name:Laryngeal Mask airway (LMA)
Description:children weighing 20 to 30 kg
Study Arm Type:Other
Arm Name:Intubating Laryngeal Airway (ILA-SP)
Description:Children weighing 20-30 kg

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Memorial Hospital

Samples and Retentions

Study Population: Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device
Sample Method:Probability Sample

Study References

Reference Type:Reference
Citation:Jagannathan N, Sohn LE, Mankoo R, Langen KE, Roth AG, Hall SC. Prospective evaluation of the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2011 Jun;21(6):673-80.
Reference Type:Reference
Citation:Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. Epub 2004 Aug 6.
Reference Type:Reference
Citation:White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. Review.

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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