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| ID | Type | Description | Link |
|---|---|---|---|
| IWK REB 4668 | Other Identifier | IWK REB number |
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A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation.
A laryngoscope is a medical instrument that is used to get a view of the voice box and the space in between the vocal cords. A laryngoscope is used to place a breathing tube into the trachea (windpipe or airway) to protect the patient's airway and provide a way to help a person breathe during surgery; this is called intubation. The placement of a breathing tube into the windpipe is a skill that is not easily mastered. In fact, the placement is difficult or impossible using the usual technique in 1-3 of every 100 patients. The ease of placing this breathing tube depends in part on how easily and how much of the vocal cords are able to be seen directly using a laryngoscope.
In a small number of patients, the Levitan First Pass Success (FPS) Scope has been shown to be more effective and easier to insert even in patients who have difficult airways. This study will evaluate the use of the LFS compared to the other conventional laryngoscope in subjects with a simulated difficult airway. The goal of this study is to determine the effectiveness and safety of the LFS in a large number of patients with simulated airway difficulties.
The results obtained during the study may provide useful information to health care providers who cannot place a breathing tube in patients that are either in operating rooms or in emergency situations requiring intubation by paramedics. An example would be a trauma situation where a paramedic is having difficulty attempting an intubation when a patients c-spine is being protected from any movements.
The LFS is an affordable and transportable device, which makes this an attractive asset for health providers in smaller community settings or in paramedic vehicles which may not have the capacity to stock or ability to afford a variety of different scopes and must choose a more limited selection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laryngoscopy order: 1) MAC, 2) Levitan | Experimental | Levitan FPS Intubation |
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| Laryngoscopy order: 1) Levitan, 2) MAC | Experimental | Macintosh Intubation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngoscopy order: 1) MAC, 2) Levitan | Device | Laryngoscopy with MAC, then Levitan |
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| Measure | Description | Time Frame |
|---|---|---|
| Cormack-Lehane Grade | The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intubation Attempts | Number of intubation attempts was recorded after intubation was completed. | intraoperative |
| Operator Rating of Difficulty | The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald B George, MD | IWK Health Centre | Principal Investigator |
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105 participants were consented and randomized, and of those 11 were withdrawn for either anticipated difficult airway, decreased SpO2, or unavailable staff/equipment. A total of 94 participants started the study protocol. 3 were withdrawn. 91 participants completed the study protocol.
From July 29,2009 to March 12, 2010 we recruited women aged 16-75 yrs old, ASA class I-II, and undergoing elective gynecologic surgery at the IWK Health Centre under general anesthesia with planned orotracheal intubation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levitan FPS/Mac Laryngoscope Intubation Order | Intubation with Levitan laryngoscopy view with Levitan : |
| FG001 | Macintosh/Levitan FPS Laryngoscope Intubation Order | traditional MAC intubation laryngoscopy view with MAC : |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Laryngoscopy order: 1) Levitan, 2) MAC | Device | Laryngoscopy with Levitan, then MAC |
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| intraoperative |
| Time to Successful Intubation | Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal. | intraoperative |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intubation Order Levitan/MAC | The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy. |
| BG001 | Intubation Order MAC/Levitan | A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Cormack-Lehane Grade | The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale. Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen | Posted | Number | participants | intraoperative |
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| Secondary | Number of Intubation Attempts | Number of intubation attempts was recorded after intubation was completed. | Not Posted | intraoperative | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Operator Rating of Difficulty | The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale. | Not Posted | intraoperative | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Successful Intubation | Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal. | Not Posted | intraoperative |
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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 | Levitan FPS Intubation | The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy. | 0 | 91 | 0 | 91 | ||
| EG001 | Macintosh Intubation | A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice) | 0 | 94 | 0 | 94 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronald George | IWK Health Centre | 902-470-6627 | rbgeorge@dal.ca |
| Male |
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