Endotracheal Tube Placement Using Totaltrack Video Laryngeal Mask Use Versus Macintosh Laryngoscope in Low Risk Patients

The purpose of this clinical study is to assess the difference in intubation difficulty scale
(IDS) score after the placement of the endotracheal tube placement (i.e. insertion of a
breathing tube through the mouth into the airway) that will occur at the beginning of general
anesthesia (i.e. combination of drugs to sedate and put you to sleep during surgery) with
TotalTrack Video Laryngeal Mask (VLM) versus conventional intubation with Macintosh curved
laryngoscope in adult patients. Both devices are approved by the US Food & Drug
Administration (FDA) for clinical use in patients. Pending partial HIPAA waiver approval,
potential subjects will be identified via review of surgery schedule on IHIS. Patients
undergoing qualifying surgeries and fit the inclusion/exclusion criteria will be approached.
Patients will be consented prior to surgery in a private room in the pre-operative area prior
to the administration of any medications that might affect their cognitive ability. The
patient will be given an opportunity to either accept or decline involvement. If he/she
declines to participate in this research study, no changes will be made to surgical or
anesthesia care, and procedure will proceed as originally planned. If the patient agrees to
participate in this research study, the following procedures will occur as part of your
participation: After the subject has signed the informed consent, a research staff member
will record information about their medical history including allergies (seasonal and drug
related), demographics (gender, age, years of education, race, and ethnicity), history of
alcohol or drug abuse, history of smoking, and history of postoperative nausea or vomiting.
All medication they have taken 7 days prior to surgery will also be recorded. In addition,
the subject will be randomly assigned (like flipping coin) to either the TotalTrack VLM or
the Macintosh curved laryngoscope. The subject has a 50/50 chance of being assigned to the
either device. The surgeon and anesthesiologist will perform routine examinations related to
surgery. This includes a physical examination and airway assessment, which are standard
before any surgical procedure. If the patient decides to take part in this study, the
anesthesiologist will perform additional assessments to further examine and characterize
their airway. This will determine whether or not the anesthesiologist anticipates controlling
your breathing during surgery (airway management) will be more difficult than usual. If your
anesthesiologist deems it appropriate, he/she will use the TotalTrack VLM or the Macintosh
curved laryngoscope for airway management according to the randomization group the subject
has been assigned. These devices are used while the subject is unconscious; the subject will
not be awake while they are being utilized. The TotalTrack VLM consists of disposable parts
connected to a reusable camera. The reusable portion will be properly cleaned between uses
per "Videotrack Instructions for Use" (uploaded). Additionally, vital signs (blood pressure,
heart rate, etc) and oxygenation measurements will be recorded using our standard monitoring
devices that the physician places as part of your routine standard of care. This data will be
collected right before, during and 5 minutes after intubation. Following intubation, after
surgery is complete, both devices will be removed and the anesthesiologist will awaken the
subject. In the recovery room, he/she will perform another airway assessment. This will
evaluate the characteristics of the subject's airway after surgery. The research staff will
record these results. Later, the research staff will conduct a follow up phone call with the
subject one week after surgery (5-9 days). After this call, research participation is
complete.