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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:
Collaborator:
Antrim Area Hospital
Information provided by:
Northern Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT00668278
First received: April 25, 2008
Last updated: January 27, 2009
Last verified: January 2009
History of Changes

April 25, 2008
January 27, 2009
February 2008
December 2008   (final data collection date for primary outcome measure)
Sealing pressure and peak airway pressure. [ Time Frame: Under anaesthesia. ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Same as current
 
 
 
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.
 
Interventional
 
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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
 

*   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
Both
18 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00668278
07/NIR01/124
No
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