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

Sponsor:	Northern Health and Social Care Trust
Collaborator:	Antrim Area Hospital
Information provided by:	Northern Health and Social Care Trust
ClinicalTrials.gov Identifier:	NCT00668278

Purpose

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.

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

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Subject), Active Control, Single Group Assignment
Official Title:	I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Further study details as provided by Northern Health and Social Care Trust:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	February 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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
B: Active Comparator I-gel insertion	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 Other: Measurement of airway pressures Measurement of peak airway pressure under steady state; measurement of device seal pressure

Eligibility

Ages Eligible for Study:	18 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668278

Sponsors and Collaborators

Northern Health and Social Care Trust

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

More Information

No publications provided

Responsible Party:	Antrim Area Hospital ( Dr William John Donaldson )
Study ID Numbers:	07/NIR01/124
Study First Received:	April 25, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00668278 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United States: Federal Government

Keywords provided by Northern Health and Social Care Trust:

Supraglottic airway
I-gel
Laryngeal mask
Controlled ventilation

Peak airway pressure
Seal pressure
Anaesthesia
Surgery

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009