NCT00668278

I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation

I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Northern Health and Social Care Trust · Other Government
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs. Hypothesis There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia. \*as defined by peak airway pressure and sealing pressures.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Insertion of laryngeal mask airway (AuraOnce mask)	Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask
DEVICE	Insertion of I-gel airway	Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg
OTHER	Measurement of airway pressures	Measurement of peak airway pressure under steady state; measurement of device seal pressure

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-12-01
• Completion: 2009-01-01
• First posted: 2008-04-29
• Last updated: 2009-01-29