Clinical Comparison of the Airway Devices

Completed · Not applicable

Conditions studied: Endotracheal Intubation, Supraglottic Airway

In brief

The purpose of this study is to evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in anesthetized patients. The study device will be compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).

Key facts

Study ID

NCT00581386

Run by

The University of Texas Health Science Center, Houston

People needed

218

Starts

2007-05-01

Expected to finish

2009-04-01

Last updated by the study team

2016-09-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subjects will be adult surgical candidates aged 18-80, ASA I-III, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
• Both male and female patients will be included.

You may not qualify if…

• Patients will be excluded from the study if they present as Mallampati III or IV, ASA IV-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA ProSeal including:
• Obesity
• Pregnancy
• History of gastric regurgitation, heart burn, ileus or "full stomach"
• History of low pulmonary compliance or high pulmonary resistance
• Known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
• Pharyngeal pathology or
• Upper airway obstruction due to laryngeal pathology.
• Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:
• Intact gag reflexes
• Height <4 feet
• Central airway obstruction
• Recent ingestion of caustic substances
• Known esophageal pathology, or
• Known latex allergy.
• They will also be excluded if any tracheal disease is present such as tracheal tumors, stenosis or previous tracheal surgery.

Where it is running

• Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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