Comparison Study of Two Supraglottic Devices Used for Patients Under General Anesthesia - Full Text View

Purpose

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 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	Intervention
Patent Airway	Device: Supraglottic airway device insertion

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA

Resource links provided by NLM:

MedlinePlus related topics: Cough

U.S. FDA Resources

Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:

Measure of the airway leak pressure [ Time Frame: After introduction of the supraglottic device ] [ Designated as safety issue: No ]
Measure of the peak airway pressure [ Time Frame: After introduction of the supraglottic device ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time needed to secure the airway [ Time Frame: From opening of the mouth to thoracic expansion and presence of ETCO2 ] [ Designated as safety issue: No ]
Number of attempts to introduce the devices [ Time Frame: At the beginning of anesthesia ] [ Designated as safety issue: No ]
Adverse effects after anesthesia (cough, sore throat, dysphagia, trauma, dysphonia) [ Time Frame: At discharge from post anesthesia care unit and on the day following surgery ] [ Designated as safety issue: No ]
Airway manipulation [ Time Frame: During anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2009

Groups/Cohorts	Assigned Interventions
I-Gel 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: Supraglottic airway device insertion In the I-Gel group, 2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA. Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. 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.
LMA Supreme 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: Supraglottic airway device insertion In the I-Gel group, 2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA. Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. 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.

Groups/Cohorts

Assigned Interventions

I-Gel

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: Supraglottic airway device insertion

In the I-Gel group, 2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA. Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.

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.

LMA Supreme

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: Supraglottic airway device insertion

In the I-Gel group, 2 attempts to secure the airway will be tried. If they both fail, there will be a crossover with a Supreme LMA. Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O.

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.

Hide Detailed Description

Detailed Description:

First of all, we will record the following demographic variables: age, sex, height, weight, BMI, surgery planned, 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/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 disparition 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 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 8mL/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 H2O.

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:

Vocal cords all visible;
Partial view of the cords including arytenoids;
View of the epiglottis only;
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 saturometer will be written before induction, after induction before insertion and at 1 and 2 minutes post insertion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Any subject planned to have general anesthesia for elective surgery

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;
ENT 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001078

Contacts

Contact: Nikola Joly, MD	+1 514 252 3426	nikola.joly@umontreal.ca
Contact: Pierre Drolet, MD, FRCPC	+1 514 252 3426	pierre.drolet@umontreal.ca

Locations

Canada, Quebec
Hôpital Maisonneuve-Rosemont	Recruiting
Montréal, Quebec, Canada, H1T 2M4

Sponsors and Collaborators

Maisonneuve-Rosemont Hospital

Investigators

Principal Investigator:

Pierre Drolet, MD, FRCPC

Hôpital Maisonneuve-Rosemont, Université de Montréal

More Information

No publications provided

Responsible Party:	Pierre Drolet, Hôpital Maisonneuve-Rosemont
ClinicalTrials.gov Identifier:	NCT01001078 History of Changes
Other Study ID Numbers:	HMR-Anesth-Joly
Study First Received:	October 21, 2009
Last Updated:	October 22, 2009
Health Authority:	Canada: Health Canada

Keywords provided by Maisonneuve-Rosemont Hospital:

supraglottic airway devices
I-Gel
Supreme Laryngeal mask airway
Airway leak pressure
peak airway pressure

ClinicalTrials.gov processed this record on May 21, 2013