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Laryngeal Mask Supreme™ Versus the I-gel™

A Comparison of The Laryngeal Mask Supreme™ and the I-gel™ in a Simulated Difficult Airway Scenario in Anesthetized and Ventilated Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00653237
Enrollment
60
Registered
2008-04-04
Start date
2008-03-31
Completion date
2008-07-31
Last updated
2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Elective General Anesthesia

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

Interventions

DEVICEI-gel and LMA Supreme: supraglottic airway devices

Insertion of a supraglottic airway device

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
first attempt success rate and time to successduring intervention

Secondary

MeasureTime frame
leak pressureduring intervention

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026