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
  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 Blind (Subject)
Primary Purpose: Health Services Research
Official Title: I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation

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
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

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
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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: Dr William John Donaldson, Antrim Area Hospital
ClinicalTrials.gov Identifier: NCT00668278     History of Changes
Other Study ID Numbers: 07/NIR01/124
Study First Received: April 25, 2008
Last Updated: January 27, 2009
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:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014