Skip to main content
OpenTrials
Completed

NCT Number: NCT01491984

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
  • Elective surgery requiring endotracheal intubation
  • English speaking
  • Age 16 - 75 years

Exclusion criteria

  • Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
  • Prior history of a difficult intubation requiring an awake tracheal intubation
  • Clinical predictors of a potentially difficult intubation requiring an awake intubation
  • BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)

Treatment and study plan

Laryngoscopy order: 1) MAC, 2) Levitan

Device

Laryngoscopy with MAC, then Levitan

Laryngoscopy order: 1) Levitan, 2) MAC

Device

Laryngoscopy with Levitan, then MAC

Primary outcomes

  1. Cormack-Lehane Grade

    Time frame: intraoperative

    The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.

    Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen

Secondary outcomes

  1. Number of Intubation Attempts

    Time frame: intraoperative

    Number of intubation attempts was recorded after intubation was completed.

  2. Operator Rating of Difficulty

    Time frame: intraoperative

    The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.

  3. Time to Successful Intubation

    Time frame: intraoperative

    Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2011
Registry last updated
Mar 10, 2015

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.

Published trials that share one or more normalized conditions with this study.