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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | Control group, taught with a standard Macintosh laryngoscope |
|
| Study group | Experimental | Study group taught with the Airtraq video laryngoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airtraq | Device | Subjects were taught with the Airtraq video laryngoscope |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Intubation | Time to intubation is the time interval of blade insertion until the removal of the laryngoscope. | 120 seconds |
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Students:
Inclusion criteria for the medical student:
Exclusion criteria for the medical student:
Patients:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gildasio DeOliveira, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
Trainees received a structured lecture in airway management followed by training in laryngoscopy skills on a mannequin, and required to demonstrate proficiency. Trainees were then randomly assigned to attempt their first two intubations on different patients using either the optical or rigid laryngoscope with a MacIntosh size 3 blade.
Medical students and intern trainees with no prior experience in laryngoscopy on clinical rotation in the Department of Anesthesiology were recruited to participate. Written informed consent was obtained from all the study participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rigid Laryngoscope Group | Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope |
| FG001 | Video Laryngoscope Group | Medical students or interns attempting intubation with Airtraq video laryngoscope |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Control group, taught with a standard Macintosh laryngoscope |
| Other |
Subjects were taught how to use the Mackintosh blade first |
|
| FG002 | Rigid Laryngoscope Patients | Patients who were intubated using the rigid laryngoscope by the medical student of intern. |
| FG003 | Video Laryngoscope Patients | Patients who were intubated using the video laryngoscope by interns or medical student. |
| COMPLETED |
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| NOT COMPLETED |
|
The 15 in each group represents the medical student/ interns who are being studied.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rigid Laryngoscope Group | Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope |
| BG001 | Video Laryngoscope Group | Medical students or interns attempting intubation with Airtraq video laryngoscope |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis. | Posted | Number | % successful | 120 seconds |
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| Secondary | Time to Intubation | Time to intubation is the time interval of blade insertion until the removal of the laryngoscope. | The sample analysis was all of the medical students or interns who consented to participate in this study. All participants data was used for the analysis. | Posted | Mean | 95% Confidence Interval | seconds | 120 seconds |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rigid Laryngoscope Group | Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope | 0 | 15 | 9 | 15 | ||
| EG001 | Video Laryngoscope Group | Medical students or interns attempting intubation with Airtraq video laryngoscope | 0 | 15 | 1 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mucosal laceration | Respiratory, thoracic and mediastinal disorders | mucosal laceration | Systematic Assessment | Oral mucosa lacerated with introduction of device. |
|
The intubating laryngeal mask airway the optical laryngoscope device used in this study does not allow for ventilation of the patient if intubation fails. We did not study retention of airway management skills between the groups.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gildasio DeOliveira | Northwestern University Feinberg School of Medicine | 312-472-3573 | g-jr@northwestern.edu |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| >=65 years |
|
| Male |
|
| 95 |
| Yes |
| Non-Inferiority or Equivalence |
Equivalence |
|