Laryngeal Masks
Conditions
Brief summary
The purpose of this study is to determine whether the leak pressure of the recently introduced laryngeal mask airway, Ambu AuraGain performs superior to the established laryngeal mask LMA Supreme in surgical patients undergoing general anesthesia. This leak pressure is the pressure at which a gas leaks around the airway, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway.
Interventions
DEVICEAmbu AuraGain
DEVICELMA Supreme
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
ASA physical status I to III Adults more above 18 years Ambulatory surgeries under general anesthesia in supine position requiring laryngeal masks- Knee arthroscopies, bladder tumour resections, hand, eye and general surgical procedures Muscle relaxant not required
Exclusion criteria
Reduced mouth opening less than 2.5 cms Recent upper respiratory tract infection and sore throat in last 2 weeks Contraindications to laryngeal mask use as in morbid obesity- BMI more than 40 and severe symptomatic esophageal reflux disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal leak pressure (OLP) for each airway device after insertion | Within 2-3 minutes after laryngeal mask insertion before start of surgery. | OLP is defined as 'the anesthesia circuit pressure at which a gas leak occurs around the SAD'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phrayngolaryngeal complications | at 1 hr, 2hr and 24 hrs after the surgery | Complications like sore throat, dysphonia, dysphagia |
| Postoperative nausea and vomiting (PONV) | at 1 hr, 2hr and 24 hrs after the surgery | PONV in the post anesthesia care unit (PACU)- PONV will be recorded as only None for No PONV and Yes for present. Severity grading will not be recorded. |
| Satisfaction of patient and the anesthesiologist with the device | After 1hr in the post anesthesia care unit (PACU) | Patient satisfaction (5 point scale)- 0 for very dissatisfied to 5 for very satisfied Anesthesiologist satisfaction scale- Low, Moderate and High |
Countries
Canada
Outcome results
None listed