A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients Undergoing Elective General Anesthesia
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- first attempt success rate and time to success
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
We evaluate two new developed airway devices, which provide patent airway during general anesthesia. In 60 patients undergoing elective general anesthesia, we will simulate a difficult airway by using an extrication device collar). We then place consecutively both airway devices in the mouth and check for ease of insertion and time used.
Detailed Description
The LMA Supreme™ and the I-gel™ are both new developed supraglottic airway devices to provide patent airways during general anesthesia. So far, prospective randomized controlled trials comparing their performance are not yet published. Both devices can be used in difficult airway situations, pre-hospital and in the hospital. In this prospective, randomized, controlled cross-over trial, we are going to evaluate the performance of both devices in a simulated difficult airway scenario using an extrication collar to limit both mouth opening and neck movement. In a maximum total of 60 patients undergoing elective surgery, we will place both airway devices consecutively and ventilate the patients. First attempt success rate and time to success will be recorded. Secondary outcomes include oropharyngeal pressure leak, ease of gastric catheter insertion, adverse events and side effects. Our hypothesis is that no difference exists between the two devices. Our 0-hypothesis is that there is a difference
Investigators
Eligibility Criteria
Inclusion Criteria
- •ASA 1-3 patients undergoing elective operation
Exclusion Criteria
- •Not speaking german or refusing to participate
- •BMI \>35, \<50kg
- •Planned operation time \>4h
- •High risk of aspiration
- •Cervical spine disease, known difficult airway, mouth opening \<20mm
- •Upper respiratory tract symptoms in the previous 10 days
- •Preoperative sore throat
- •Poor dentition with high risk of damage
Outcomes
Primary Outcomes
first attempt success rate and time to success
Time Frame: during intervention
Secondary Outcomes
- leak pressure(during intervention)