Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
Condition: Deglutition Disorders
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Maintaining low (15mmHg) ETT cuff pressure; Maintaining a normal pressure in the ETT cuff
Intervention type(s): Procedure; Procedure
Intervention description(s): Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg; No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dysphagia; spine surgery; cuff pressure