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

NCT01491984 | Completed Phase 4 Results DMC

• 2 other identifiers: IWK-4668-2009IWK REB 4668
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Airway Complication of Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of Intubation Attempts

  intraoperative

• Operator Rating of Difficulty

  intraoperative

• Time to Successful Intubation

  intraoperative

Study Arms (2)

Laryngoscopy order: 1) MAC, 2) Levitan

EXPERIMENTAL

Levitan FPS Intubation

Device: Laryngoscopy order: 1) MAC, 2) Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC

Laryngoscopy order: 1) Levitan, 2) MAC

EXPERIMENTAL

Macintosh Intubation

Device: Laryngoscopy order: 1) MAC, 2) Levitan; Device: Laryngoscopy order: 1) Levitan, 2) MAC

Interventions

Laryngoscopy order: 1) MAC, 2) Levitan DEVICE

Laryngoscopy with MAC, then Levitan

Laryngoscopy order: 1) Levitan, 2) MAC; Laryngoscopy order: 1) MAC, 2) Levitan

Laryngoscopy order: 1) Levitan, 2) MAC DEVICE

Laryngoscopy with Levitan, then MAC

Laryngoscopy order: 1) Levitan, 2) MAC; Laryngoscopy order: 1) MAC, 2) Levitan

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II (healthy or mild systemic disease, ex. asthma, high blood pressure)
• Elective surgery requiring endotracheal intubation
• English speaking
• Age 16 - 75 years

You may not qualify if:

• Significant gastroesophageal reflux disease (GERD) that may require alternate induction/intubation techniques
• Prior history of a difficult intubation requiring an awake tracheal intubation
• Clinical predictors of a potentially difficult intubation requiring an awake intubation
• BMI \> 45 kg/m2 (Obesity is a common and important risk factor for difficult intubation)

Sponsors & Collaborators

• IWK Health Centre: lead

Results Point of Contact

• Title: Dr. Ronald George
• Organization: IWK Health Centre

rbgeorge@dal.ca

902-470-6627

Study Officials

• Ronald B George, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 14, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 10, 2015
• Results First Posted: March 10, 2015

Record last verified: 2015-02