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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01491984
First received: December 12, 2011
Last updated: February 24, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention Phase
Airway Complication of Anaesthesia
Device: Laryngoscopy order: 1) MAC, 2) Levitan
Device: Laryngoscopy order: 1) Levitan, 2) MAC
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Cormack-Lehane Grade [ Time Frame: intraoperative ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Number of Intubation Attempts [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    Number of intubation attempts was recorded after intubation was completed.

  • Operator Rating of Difficulty [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    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.

  • Time to Successful Intubation [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    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.


Enrollment: 105
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laryngoscopy order: 1) MAC, 2) Levitan
Levitan FPS Intubation
Device: Laryngoscopy order: 1) MAC, 2) Levitan
Laryngoscopy with MAC, then Levitan
Device: Laryngoscopy order: 1) Levitan, 2) MAC
Laryngoscopy with Levitan, then MAC
Experimental: Laryngoscopy order: 1) Levitan, 2) MAC
Macintosh Intubation
Device: Laryngoscopy order: 1) MAC, 2) Levitan
Laryngoscopy with MAC, then Levitan
Device: Laryngoscopy order: 1) Levitan, 2) MAC
Laryngoscopy with Levitan, then MAC

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

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491984

Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Ronald B George, MD IWK Health Centre
  More Information

No publications provided

Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01491984     History of Changes
Other Study ID Numbers: IWK-4668-2009, IWK REB 4668
Study First Received: December 12, 2011
Results First Received: May 22, 2013
Last Updated: February 24, 2015
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on May 05, 2015