NCT01385761 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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. Review.

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

Clinical trial NCT01385761 - References