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

NCT01385761 | Completed

• 1 other identifier: IRB#2011-14642
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Children

Keywords

Supraglottic airway devices

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  2 months

Study Arms (2)

Laryngeal Mask airway (LMA)

children weighing 20 to 30 kg

Device: Laryngeal Mask Airway

Intubating Laryngeal Airway (ILA-SP)

Children weighing 20-30 kg

Device: air-QTM Intubating Laryngeal Airway

Interventions

Laryngeal Mask Airway 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.

Also known as: Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA)

Laryngeal Mask airway (LMA)

air-QTM Intubating Laryngeal Airway 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.

Also known as: air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA

Intubating Laryngeal Airway (ILA-SP)

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device

You may qualify if:

• Children undergoing general anesthesia using a supraglottic airway device
• to 9 years of age
• to 30 kilograms in weight

You may not qualify if:

• History of a difficult airway
• Active gastrointestinal reflux
• Active upper respiratory tract infection

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Childrens Memorial Hospital

Chicago, Illinois, 60618, United States

Location

Related Publications (3)

• 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.

  PMID: 21518103 BACKGROUND

• 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.

  PMID: 15298876 BACKGROUND

• 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: 19572845 BACKGROUND

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, 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: primary investigator

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

US (1)