Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study

Conditions
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Deglutition Disorders

Intervention / Treatment
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* Procedure: Maintaining low (15mmHg) ETT cuff pressure
* Procedure: Maintaining a normal pressure in the ETT cuff


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 21 and 65 years of age Must be competent to give consent Undergoing a first time anterior cervical discectomy (ACD) with instrumentation to remove pressure from the nerve roots caused by bone spurs or herniated disc material which is documented by a diagnostic procedure (CT and/or MRI)*. Ability and willingness to participate in routine follow-up at 6 weeks, 3 months and 6 months following surgery*. Exclusion Criteria: Previous anterior neck surgery Anterior neck malignancy Tracheostomy. Previous treatment for dysphagia Pregnancy Women of childbearing potential who are not using an effective method of contraception. Medical comorbidities (e.g. significant renal or hepatic disease) which, in the investigator's opinion, may interfere with the patient's suitability and participation in the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients randomly assigned to this group will have no changes in the ETT during surgery | Procedure: Maintaining a normal pressure in the ETT cuff<br>* No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff<br>|
| Experimental: Treatment group<br>Patients in this group will undergo same surgery as control group but with a monitoring and manipulation of ETT pressure | Procedure: Maintaining low (15mmHg) ETT cuff pressure<br>* Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of dysphagia |  | pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall health score |  | pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery | 
| Percentage change in anterior cervical soft-tissue thickness on plain lateral radiographs |  | pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery | 
| Cost-effectiveness |  | 6mons after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, spine surgery, cuff pressure