Clinical trial NCT01491984: Effectiveness and Safety of the Levitan Scope for Laryngoscopy and Tracheal Intubation With a Simulated Difficult Airway
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Airway Complication of Anaesthesia
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 105
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cormack-Lehane Grade
timeFrame: intraoperative
Secondary outcomes:
measure: Number of Intubation Attempts
timeFrame: intraoperative
measure: Operator Rating of Difficulty
timeFrame: intraoperative
measure: Time to Successful Intubation
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Ronald B George, MD
role: PRINCIPAL_INVESTIGATOR
References: