Intubation Intraesophageal Clinical Trial
Official title:
A Clinical Trial on the Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
Verified date | October 2013 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Country | Name | City | State |
---|---|---|---|
United States | Northwestern Memorial Hospital | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful Endotracheal Intubation | 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 | No |
Secondary | Time to Intubation | Time to intubation is the time interval of blade insertion until the removal of the laryngoscope. | 120 seconds | No |
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