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

NCT ID: NCT01491984

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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.

Conditions

Airway Complication of Anaesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laryngoscopy order: 1) MAC, 2) Levitan

Levitan FPS Intubation

Group Type: EXPERIMENTAL

Laryngoscopy order: 1) MAC, 2) Levitan

Intervention Type: DEVICE

Laryngoscopy with MAC, then Levitan

Laryngoscopy order: 1) Levitan, 2) MAC

Intervention Type: DEVICE

Laryngoscopy with Levitan, then MAC

Laryngoscopy order: 1) Levitan, 2) MAC

Macintosh Intubation

Group Type: EXPERIMENTAL

Laryngoscopy order: 1) MAC, 2) Levitan

Intervention Type: DEVICE

Laryngoscopy with MAC, then Levitan

Laryngoscopy order: 1) Levitan, 2) MAC

Intervention Type: DEVICE

Laryngoscopy with Levitan, then MAC

Interventions

Laryngoscopy order: 1) MAC, 2) Levitan

Laryngoscopy with MAC, then Levitan

Intervention Type: DEVICE

Laryngoscopy order: 1) Levitan, 2) MAC

Laryngoscopy with Levitan, then MAC

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IWK Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Ronald George

Primary Investigator, MD, FRCPC, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald B George, MD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Other Identifiers

IWK REB 4668

Identifier Type: OTHER

Identifier Source: secondary_id

IWK-4668-2009

Identifier Type: -

Identifier Source: org_study_id