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Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia

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ClinicalTrials.gov Identifier: NCT01001078
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Nikola Joly, Maisonneuve-Rosemont Hospital

Study Description
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Brief Summary:
This study will compare two supraglottic airway devices currently on the market. Supraglottic airway devices are used during general anesthesia to provide a patent airway. They are inserted blindly into the mouth once the patient has lost consciousness and they cover the laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to be compared. The I-Gel has no inflatable cuff, which makes it different from all other supraglottic airway devices currently in use. The Supreme shares some characteristics of the other LMA devices, but it is disposable. Our main goal will be to compare the airway leak pressure and the peak airway pressure of each devices. We will also measure the time needed for insertion, number of attempts needed to secure the airway and side effects related to the airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).

Condition or disease Intervention/treatment Phase
Anesthesia Airway Management Device: I-Gel supraglottic airway device Device: LMA Supreme supraglottic airway device Device: Standard endotracheal tube Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA
Study Start Date : September 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: I-Gel supraglottic airway device
Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
 Device: I-Gel supraglottic airway device
2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA.

Device: Standard endotracheal tube
In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted
Active Comparator: LMA Supreme supraglottic airway device
Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
 Device: LMA Supreme supraglottic airway device
In the LMA Supreme group, the same interventions will be done as in the I-Gel group. The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Leak pressure will also be measure at 45 mL. Once the leak test is done, the cuff will be deflated to initial volume necessary to avoid audible leaks.

Device: Standard endotracheal tube
In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted
Active Comparator: Standard endotracheal tube
A Standard endotracheal tube will be inserted in case both other airway devices (LMA Supreme and iGel) devices fail to provide adequate ventilation.
 Device: Standard endotracheal tube
In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted


Outcome Measures
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Primary Outcome Measures :
  1. Measure of the Airway Leak Pressure [ Time Frame: After introduction of the supraglottic device before the beginning of the surgery. ]

Secondary Outcome Measures :
  1. Measure of the Peak Airway Pressure [ Time Frame: After introduction of the SAD before the beginning of the surgery. ]
  2. Time Needed to Secure the Airway [ Time Frame: From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes. ]
  3. Number of Participants With Successful Attempts to Introduce the Devices [ Time Frame: At the beginning of anesthesia before the beginning of the surgery. ]
  4. Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia) [ Time Frame: On the day following surgery ]
    Intent to treat assessment of adverse events, per intervention, was intended. The adverse effects were assessed by phone; or in person if patient in the hospital; on the following day.

  5. Airway Manipulation and Blood on Device at Removal [ Time Frame: During and after anesthesia when the device is removed. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Weight more than 50 kg;
  • Body Mass Index less than 30;
  • ASA I to III.

Exclusion Criteria:

  • Symptomatic gastro oesophageal reflux disease (GERD);
  • Non fasted patients;
  • Nasogastric tube in place;
  • Intestinal obstruction;
  • Ear, nose and throat surgery in the past or deformation of the airway;
  • Known difficult airway (Cormack-Lehane grade 3-4);
  • Oral cavity opening less than 3 cm;
  • Pregnancy.
Contacts and Locations
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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): NCT01001078


Locations
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Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
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Principal Investigator: Pierre Drolet, MD, FRCPC Hôpital Maisonneuve-Rosemont, Université de Montréal
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nikola Joly, MD, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01001078    
Other Study ID Numbers: HMR-Anesth-Joly
First Posted: October 23, 2009    Key Record Dates
Results First Posted: January 22, 2015
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by Nikola Joly, Maisonneuve-Rosemont Hospital:
supraglottic airway devices
I-Gel
Supreme Laryngeal mask airway
Airway leak pressure
peak airway pressure