Prospective Randomized Trial Comparing the Performance of Two Supraglottic Airway Management Devices: I-Gel and Supreme LMA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Measure of the Airway Leak Pressure
Study Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: I-Gel supraglottic airway device (Device)
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.
Intervention: Standard endotracheal tube (Device)
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.
Intervention: LMA Supreme supraglottic airway device (Device)
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.
Intervention: Standard endotracheal tube (Device)
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.
Intervention: Standard endotracheal tube (Device)
Outcomes
Primary Outcomes
Measure of the Airway Leak Pressure
Time Frame: After introduction of the supraglottic device before the beginning of the surgery.
Secondary Outcomes
- Measure of the Peak Airway Pressure(After introduction of the SAD before the beginning of the surgery.)
- Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia)(On the day following surgery)
- Time Needed to Secure the Airway(From opening of the mouth to thoracic expansion and presence of End Tidal CO2 up to five minutes.)
- Airway Manipulation and Blood on Device at Removal(During and after anesthesia when the device is removed.)
- Number of Participants With Successful Attempts to Introduce the Devices(At the beginning of anesthesia before the beginning of the surgery.)
Investigators
Nikola Joly
MD
Maisonneuve-Rosemont Hospital