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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Device: Insertion of laryngeal mask airway (AuraOnce mask)
* Device: Insertion of I-gel airway
* Other: Measurement of airway pressures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females. Age 18-89 inclusive. ASA grade 1-2. Elective surgery Exclusion Criteria: Emergency surgery. Surgery within the peritoneum. Surgery requiring prone or steep head-down positioning. Patients at increased risk of aspiration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Laryngeal Mask Airway insertion | Device: Insertion of laryngeal mask airway (AuraOnce mask)<br>* Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask<br>Other: Measurement of airway pressures<br>* Measurement of peak airway pressure under steady state; measurement of device seal pressure<br>|
| Active Comparator: B<br>I-gel insertion | Device: Insertion of I-gel airway<br>* Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg<br>Other: Measurement of airway pressures<br>* Measurement of peak airway pressure under steady state; measurement of device seal pressure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealing pressure and peak airway pressure. |  | Under anaesthesia. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative patient symptoms |  | 1hr and 24hrs postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic airway, I-gel, Laryngeal mask, Controlled ventilation, Peak airway pressure, Seal pressure, Anaesthesia, Surgery