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

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ClinicalTrials.gov Identifier: NCT01491984
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre

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.

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

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491984


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

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 ( Other Identifier: IWK REB number )
First Posted: December 14, 2011    Key Record Dates
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015
Last Verified: February 2015