Healthy
Conditions
Keywords
Supraglottic airway, I-gel, Laryngeal mask, Controlled ventilation, Peak airway pressure, Seal pressure, Anaesthesia, Surgery
Brief summary
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs. Hypothesis There is no difference between the performance\* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia. \*as defined by peak airway pressure and sealing pressures.
Interventions
DEVICEInsertion of laryngeal mask airway (AuraOnce mask)
Insertion of laryngeal mask airway under anaesthesia: Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg; AuraOnce disposable laryngeal mask
DEVICEInsertion of I-gel airway
Insertion of I-gel airway under anaesthesia; Fentanyl 1-2mcg/kg; Propofol 1-3mg/kg; Atracurium 0.5mg/kg
OTHERMeasurement of airway pressures
Measurement of peak airway pressure under steady state; measurement of device seal pressure
Sponsors
Antrim Area Hospital
Northern Health and Social Care Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females. * Age 18-89 inclusive. * ASA grade 1-2. * Elective surgery
Exclusion criteria
* Emergency surgery. * Surgery within the peritoneum. * Surgery requiring prone or steep head-down positioning. * Patients at increased risk of aspiration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sealing pressure and peak airway pressure. | Under anaesthesia. |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative patient symptoms | 1hr and 24hrs postoperatively |
Outcome results
None listed