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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668278
First Posted: April 29, 2008
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Antrim Area Hospital
Information provided by:
Northern Health and Social Care Trust
  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: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

Resource links provided by NLM:


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. ]

Secondary Outcome Measures:
  • Postoperative patient symptoms [ Time Frame: 1hr and 24hrs postoperatively ]

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
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr William John Donaldson, Antrim Area Hospital
ClinicalTrials.gov Identifier: NCT00668278     History of Changes
Other Study ID Numbers: 07/NIR01/124
First Submitted: April 25, 2008
First Posted: April 29, 2008
Last Update Posted: January 29, 2009
Last Verified: January 2009

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:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs