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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-01-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Laryngeal Mask Airway insertion

Group Type ACTIVE_COMPARATOR

Insertion of laryngeal mask airway (AuraOnce mask)

Intervention Type DEVICE

Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask

Measurement of airway pressures

Intervention Type OTHER

Measurement of peak airway pressure under steady state; measurement of device seal pressure

B

I-gel insertion

Group Type ACTIVE_COMPARATOR

Insertion of I-gel airway

Intervention Type DEVICE

Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg

Measurement of airway pressures

Intervention Type OTHER

Measurement of peak airway pressure under steady state; measurement of device seal pressure

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Measurement of airway pressures

Measurement of peak airway pressure under steady state; measurement of device seal pressure

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes