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

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ClinicalTrials.gov Identifier: NCT00668278
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : January 29, 2009
Sponsor:
Collaborator:
Information provided by:

April 25, 2008
April 29, 2008
January 29, 2009
February 2008
December 2008   (Final data collection date for primary outcome measure)
Sealing pressure and peak airway pressure. [ Time Frame: Under anaesthesia. ]
Same as current
Complete list of historical versions of study NCT00668278 on ClinicalTrials.gov Archive Site
Postoperative patient symptoms [ Time Frame: 1hr and 24hrs postoperatively ]
Same as current
Not Provided
Not Provided
 
I-Gel Versus Disposable Laryngeal Mask (LMA) for General Anesthesia (GA) With Controlled Ventilation
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Healthy
  • 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
  • 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
  • Active Comparator: A
    Laryngeal Mask Airway insertion
    Interventions:
    • Device: Insertion of laryngeal mask airway (AuraOnce mask)
    • Other: Measurement of airway pressures
  • Active Comparator: B
    I-gel insertion
    Interventions:
    • Device: Insertion of I-gel airway
    • Other: Measurement of airway pressures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
January 2009
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 89 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United Kingdom
 
NCT00668278
07/NIR01/124
No
Not Provided
Not Provided
Dr William John Donaldson, Antrim Area Hospital
Northern Health and Social Care Trust
Antrim Area Hospital
Principal Investigator: William J Donaldson, MBBS FRCA Antrim Area Hospital, Northern Health and Social Care Trust, National Health Service, United Kingdom
Northern Health and Social Care Trust
January 2009

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