Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway

Airway Complication of Anaesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491984
• Other study ID #: IWK-4668-2009
• Secondary ID: IWK REB 4668
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2011
• Last updated: February 24, 2015
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: February 2015
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)

2. Elective surgery requiring endotracheal intubation

3. English speaking

4. Age 16 - 75 years

Exclusion Criteria:

1. Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques

2. Prior history of a difficult intubation requiring an awake tracheal intubation

3. Clinical predictors of a potentially difficult intubation requiring an awake intubation

4. BMI > 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Complication of Anaesthesia

Intervention

Device:
• Laryngoscopy order: 1) MAC, 2) Levitan
Laryngoscopy with MAC, then Levitan
• Laryngoscopy order: 1) Levitan, 2) MAC
Laryngoscopy with Levitan, then MAC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cormack-Lehane Grade	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	intraoperative	No
Secondary	Number of Intubation Attempts	Number of intubation attempts was recorded after intubation was completed.	intraoperative	No
Secondary	Operator Rating of Difficulty	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.	intraoperative	No
Secondary	Time to Successful Intubation	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.	intraoperative	No