Deglutition Disorders Clinical Trial
Official title:
Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study
Anterior cervical spine surgery (ACSS) is one of the most common procedures performed by
spinal surgeons. It is associated with a 30-50% risk of developing swallowing difficulties
(dysphagia). Although these difficulties usually improve within 6 months, for some it remains
a significant and persistent problem.
We hypothesize that lowering the cuff pressure will lower the risk of injury to soft-tissues
in the neck that are important to swallowing function. Our objective in this study is to
demonstrate a lower occurrence of swallowing problems after anterior cervical spine surgery
in patients with lower endotracheal tube cuff pressure during surgery.
Forty patients will be randomly assigned to a treatment group or control group. The treatment
group will have the cuff pressure maintained at 15mmHg during the entire duration of the
procedure. The control group will have the cuff pressure monitored without manipulation.
After surgery soft-tissue swelling will be assessed on the five routine neck x-rays taken. In
addition, 3 questionnaires completed before surgery and at each scheduled follow-up
appointment will measure and track changes in swallowing over time and assess the impact of
swallowing function on the patient's overall health. The results of this study may show that
making a minor, inexpensive change during an operation may lower the risk of swallowing
difficulties after a relatively common surgery.
Post-operative dysphagia is a well-documented complication of anterior cervical spine surgery
(ACSS) with an estimated risk of 30 - 50% that patients will experience some degree of
post-operative swallowing dysfunction. While symptoms often subside within 6 months the
impact of swallowing difficulties may be far reaching within the health-care system. Patients
may be at risk of aspiration pneumonia and require swallowing assessments and modified diets.
These measures necessitate a prolonged hospital stay. Patients may be prescribed
anti-inflammatory medications and steroids which can inhibit bony fusion, which is an
essential component of healing and ensuring spinal stability following ACSS.
The ultimate goal of this project is to determine the effect of minimizing ETT cuff pressure
on the frequency of post-operative dysphagia following ACD. We believe that maintaining the
ETT cuff pressure at 15mmHg will decrease the incidence of post-operative dysphagia - a
direct benefit to the patients in the treatment group. Maintaining the ETT cuff pressure at
15mmHg would require no additional intra-operative equipment or modification to existing
equipment. This intervention would not modify standard operative practice or pose additional
risks to patients. As a result the cost-to-benefit ratio of this intervention may be
substantially favourable to patients and the health care system.
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