Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.
In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.
The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.
The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effectiveness and Safety of the Levitan FPS Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway in Surgical Subjects Under General Anesthesia|
- laryngoscopy view grading [ Time Frame: intraoperative ] [ Designated as safety issue: No ]during intubation
- number of intubation attempts [ Time Frame: intraoperative ] [ Designated as safety issue: No ]during intubation
- operator rating of difficulty [ Time Frame: intraoperative ] [ Designated as safety issue: No ]during intubation
- time ot successful intubation [ Time Frame: intraoperative ] [ Designated as safety issue: No ]during intubation
|Study Start Date:||July 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Levitan
Intubation with Levitan
Active Comparator: MAC
traditional MAC intubation