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

January 13, 2015 updated by: Nikola Joly, Maisonneuve-Rosemont Hospital

Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

First of all, we will record the following demographic variables: age, sex, height, weight, BMI, surgery planned, American Society of Anesthesiology (ASA) status, dental state (good, bad, edentulous), tobacco use (none, ceased, active) and packs year, Mallampati score, thyromental distance and whether or not there is trauma on the tongue, teeth or lips prior to surgery.

Induction of anesthesia will be standardized with Fentanyl 1-3 mcg/kiloGram(kG) and Propofol 1-3,5 mg/kG. The use of myorelaxant will be mandatory, but either succinylcholine or rocuronium will be used as long as complete disappearance of T1 is observed before attempting supraglottic airway insertion.

Prior to insertion, ease of ventilation (yes/no) will be noted.

The two airway devices will be used according to manufacturers instructions. The sizes of the devices will be chosen according to weight:

I-Gel: 50-90 kG: #4 and 90 Kg and up: #5 LMA Supreme: 50-70 Kg: #4 and 70-100 Kg: #5.

Patients will be randomized in either I-Gel or LMA Supreme group. Two insertions with the same device will be allowed before a crossover to the other device. If the third attempt fails, a standard endotracheal tube will be put in the trachea and blood in the oral cavity will be sought. After each failed attempt (no thoracic expansion, no carbon dioxide (CO2) square wave or leak at standardized volume. Blood on the devices will also be recorded.

Since the LMA Supreme has a cuff, we will inflate it to 25 mL and then by intervals of 5 mL of air (max 45 mL) we will inflate it at a volume where no audible leak is heard at a standardized ventilation scheme of volume controlled 8 mL/kg X 10 breaths per minute.

Once fixed with tape, we will measure peak and mean airway pressure for three breaths after 30 seconds of volume controlled breathing. Then the fresh gas flow will be fixed at 3 L/min of 50-50 air-oxygen blend and the Adjustable Pressure Limiting valve will be closed. We will look either for a plateau pressure at which a leak equal to the fresh gas flow or a pressure of 40 cm of water.

We will sought adverse effect like bronchospasm, cough, regurgitation, desaturation, aspiration and deglutition movement.

Ease of insertion will be score on a scale of 1 to 4. 1 being very easy and 4 being very hard.

Endoscopic evaluation will take place afterwards. First in the ventilation tube. Scoring for laryngeal view:

  1. Vocal cords all visible;
  2. Partial view of the cords including arytenoids;
  3. View of the epiglottis only;
  4. Other (LMA or pharynx).

Downfolding of the epiglottis will be sought.

Then we will go through the oesophageal port and see if the oesophageal mucosa il visible.

During surgery, we will check if airway manipulation and/or withdrawal was necessary and why.

If traces of blood on the devices are present at the end of the intervention it will be noted.

Two interviews will take place one at the post anesthesia care unit and another the following day by phone if the patient was having ambulatory surgery. Sore throat, cough, dysphagia and dysphonia will be asked to be graded: absent, mild, moderate or severe.

Pulse and arterial pressure with the operating room's sphygmomanometer and oximeter will be written before induction, after induction before insertion and at 1 and 2 minutes post insertion.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: Standard endotracheal tube
In case both supraglottic airway devices fail, a standard endotracheal tube will be inserted
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure of the Airway Leak Pressure
Time Frame: After introduction of the supraglottic device before the beginning of the surgery.
After introduction of the supraglottic device before the beginning of the surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the Peak Airway Pressure
Time Frame: After introduction of the SAD before the beginning of the surgery.
After introduction of the SAD before the beginning of the surgery.
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.
From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.
Number of Participants With Successful Attempts to Introduce the Devices
Time Frame: At the beginning of anesthesia before the beginning of the surgery.
At the beginning of anesthesia before the beginning of the surgery.
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.
On the day following surgery
Airway Manipulation and Blood on Device at Removal
Time Frame: During and after anesthesia when the device is removed.
During and after anesthesia when the device is removed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

  • Principal Investigator: Pierre Drolet, MD, FRCPC, Hôpital Maisonneuve-Rosemont, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 22, 2015

Last Update Submitted That Met QC Criteria

January 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMR-Anesth-Joly

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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