Comparison of I-gel to the Laryngeal Mask Airway

Completed · Not applicable

Conditions studied: Endotracheal Intubation, Supraglottic Airway

In brief

The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.

Key facts

Study ID

NCT00706823

Run by

The University of Texas Health Science Center, Houston

People needed

50

Starts

2008-02-01

Expected to finish

2008-08-01

Last updated by the study team

2017-02-20

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-II, 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 III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
• obesity, (BMI > 35 kg/m2)
• 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
• upper airway obstruction due to laryngeal pathology

Where it is running

• Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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