Skip to main content
OpenTrials
Completed

NCT Number: NCT00653237

Laryngeal Mask Supreme™ Versus the I-gel™

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Bern, Canton of Bern, CH-3010, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel and LMA Supreme: supraglottic airway devices

Device

Insertion of a supraglottic airway device

Other names: Laryngeal Mask Supreme, supraglottic airway device

Primary outcomes

  1. first attempt success rate and time to success

    Time frame: during intervention

Secondary outcomes

  1. leak pressure

    Time frame: during intervention

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 4, 2008
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.