- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080118
Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
October 29, 2013 updated by: Gildasio De Oliveira, Northwestern University
A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: control group
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
|
Subjects were taught with the Airtraq video laryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
120 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Intubation
Time Frame: 120 seconds
|
Time to intubation is the time interval of blade insertion until the removal of the laryngoscope.
|
120 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gildasio DeOliveira, MD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
February 26, 2010
First Submitted That Met QC Criteria
March 2, 2010
First Posted (Estimate)
March 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 2, 2013
Last Update Submitted That Met QC Criteria
October 29, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STU00007644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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