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Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080118
First Posted: March 3, 2010
Last Update Posted: December 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
  Purpose
The use of the video laryngoscope to teach laryngoscopy will improve the performance of tracheal intubation done by novices because it will allow a shared view of the airway leading to a better feedback from the trainer to the trainee.

Condition Intervention
Intubation Intraesophageal Device: Airtraq Other: Control group, taught with a standard Macintosh laryngoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices

Further study details as provided by Gildasio De Oliveira, Northwestern University:

Primary Outcome Measures:
  • Successful Endotracheal Intubation [ Time Frame: 120 seconds ]
    A successful placement of the endotracheal tube as defined by the presence of bilateral breath sounds and positive recording of end tidal carbon dioxide.


Secondary Outcome Measures:
  • Time to Intubation [ Time Frame: 120 seconds ]
    Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.


Enrollment: 90
Study Start Date: February 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control group
Control group, taught with a standard Macintosh laryngoscope
Other: Control group, taught with a standard Macintosh laryngoscope
Subjects were taught how to use the Mackintosh blade first
Experimental: Study group
Study group taught with the Airtraq video laryngoscope
Device: Airtraq
Subjects were taught with the Airtraq video laryngoscope

Detailed Description:
A group of 30 fourth year medical students and interns rotating through the department of anesthesiology will be studied. Firstly, a standard lecture will be provided in which the description and importance of laryngoscopy and tracheal intubation will be explained. This will include descriptions of anatomy, relevant equipment and technique of tracheal intubation. Following the lecture , the students will be randomly allocated using sealed envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope ) and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation by their instructor.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Students:

Inclusion criteria for the medical student:

  • Medical student or intern rotating through the anesthesiology department

Exclusion criteria for the medical student:

  • Previous attempts of laryngoscopy in humans
  • Subject who refuses participation

Patients:

Inclusion Criteria:

  • Age 18 -75 years of age
  • ASA PS I, II
  • Procedure that will require General anesthesia with tracheal intubation

Exclusion Criteria:

  • Age < 18 years old or greater than 75 years of age
  • Patient or student who refuses participation
  • ASA Physical status class III or greater
  • History of lung disease
  • History of obstructive sleep apnea
  • History of difficult intubation
  • Evidence of possible difficult airway (Mallampati Class >2, TMH distance <6 cm, mouth opening <4 cm and limited neck mobility)
  • Unanticipated difficult laryngoscopy (defined by inability of the attending anesthesiology to intubate after 2 attempts)
  • Patients at risk for aspiration
  • Patients with BMI greater than 35
  • Pregnant patients
  Contacts and Locations
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): NCT01080118


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
  More Information

Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01080118     History of Changes
Other Study ID Numbers: STU00007644
First Submitted: February 26, 2010
First Posted: March 3, 2010
Results First Submitted: March 2, 2012
Results First Posted: September 4, 2013
Last Update Posted: December 2, 2013
Last Verified: October 2013

Keywords provided by Gildasio De Oliveira, Northwestern University:
Teaching
Video Scope
Intubation