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

Northern Health and Social Care Trust

Status: Completed

Conditions: Healthy

Treatments: Device: Insertion of laryngeal mask airway (AuraOnce mask); Device: Insertion of I-gel airway; Other: Measurement of airway pressures

Study type: Interventional

Funder types: Other

Identifiers

NCT00668278

07/NIR01/124

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 2 patient groups

A

Active Comparator group

Description:

Laryngeal Mask Airway insertion

Treatment:

Other: Measurement of airway pressures

Device: Insertion of laryngeal mask airway (AuraOnce mask)

B

Active Comparator group

Description:

I-gel insertion

Treatment:

Device: Insertion of I-gel airway

Other: Measurement of airway pressures