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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080118
Other study ID # STU00007644
Secondary ID
Status Completed
Phase N/A
First received February 26, 2010
Last updated October 29, 2013
Start date February 2010
Est. completion date February 2011

Study information

Verified date October 2013
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Device:
Airtraq
Subjects were taught with the Airtraq video laryngoscope
Other:
Control group, taught with a standard Macintosh laryngoscope
Subjects were taught how to use the Mackintosh blade first

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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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