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

NCT ID: NCT01385761

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-03-31

Brief Summary

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.

Detailed Description

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.

Conditions

Children

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Laryngeal Mask airway (LMA)

children weighing 20 to 30 kg

Laryngeal Mask Airway

Intervention Type: DEVICE

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Intubating Laryngeal Airway (ILA-SP)

Children weighing 20-30 kg

air-QTM Intubating Laryngeal Airway

Intervention Type: DEVICE

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Interventions

Laryngeal Mask Airway

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Intervention Type: DEVICE

air-QTM Intubating Laryngeal Airway

Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.

Intervention Type: DEVICE

Other Intervention Names

Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA); air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Narasimhan Jagannathan

primary investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narasimhan Jagannathan, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Memorial Hospital

Locations

Childrens Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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. doi: 10.1111/j.1460-9592.2011.03576.x.

Reference Type: BACKGROUND

PMID: 21518103 (View on PubMed)

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. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.

Reference Type: BACKGROUND

PMID: 15298876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19572845 (View on PubMed)

Other Identifiers

IRB#2011-14642

Identifier Type: -

Identifier Source: org_study_id