Expired Study
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Chicago, Illinois 60618


Purpose:

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.


Criteria:

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:

IRB#2011-14642


NCT ID:

NCT01385761


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:

Completed


Study Phase:

N/A


Genders:

Both


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:

Observational


Study Design:

Observational Model: Case Control, Time Perspecti


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

60


Enrollment Type:

Actual


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.
PMID:21518103
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.
PMID:15298876
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.
PMID:19572845

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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