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

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

January 27, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sealing pressure and peak airway pressure. [ Time Frame: Under anaesthesia. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668278 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Postoperative patient symptoms [ Time Frame: 1hr and 24hrs postoperatively ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Health Services Research, Randomized, Single Blind (Subject), Active Control, Single Group Assignment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Laryngeal Mask Airway insertion
Active Comparator: I-gel insertion

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

January 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 89 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00668278

Responsible Party

Dr William John Donaldson, Antrim Area Hospital

Study ID Numbers ^ICMJE

07/NIR01/124

Study Sponsor ^ICMJE

Northern Health and Social Care Trust

Collaborators ^ICMJE

Antrim Area Hospital

Investigators ^ICMJE

Principal Investigator:

William J Donaldson, MBBS FRCA

Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom

Information Provided By

Northern Health and Social Care Trust

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP