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

January 27, 2009 updated by: Northern Health and Social Care Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Laryngeal Mask Airway insertion
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
Other: Measurement of airway pressures
Measurement of peak airway pressure under steady state; measurement of device seal pressure
Active Comparator: B
I-gel insertion
Other: Measurement of airway pressures
Measurement of peak airway pressure under steady state; measurement of device seal pressure
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sealing pressure and peak airway pressure.
Time Frame: Under anaesthesia.
Under anaesthesia.

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative patient symptoms
Time Frame: 1hr and 24hrs postoperatively
1hr and 24hrs postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Health and Social Care Trust

Collaborators

Antrim Area Hospital

Investigators

  • Principal Investigator: William J Donaldson, MBBS FRCA, Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 07/NIR01/124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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