Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
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|ClinicalTrials.gov Identifier: NCT00332683|
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : August 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Deglutition Disorders||Procedure: Maintaining low (15mmHg) ETT cuff pressure Procedure: Maintaining a normal pressure in the ETT cuff||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study|
|Actual Study Start Date :||June 6, 2006|
|Actual Primary Completion Date :||July 31, 2013|
|Actual Study Completion Date :||July 31, 2013|
Active Comparator: Control
Patients randomly assigned to this group will have no changes in the ETT during surgery
Procedure: Maintaining a normal pressure in the ETT cuff
No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
Experimental: Treatment group
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
Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
- Severity of dysphagia [ Time Frame: pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery ]
- Overall health score [ Time Frame: pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery ]
- Percentage change in anterior cervical soft-tissue thickness on plain lateral radiographs [ Time Frame: pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery ]
- Cost-effectiveness [ Time Frame: 6mons after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332683
|London Health Sciences Center, University Campus|
|London, Ontario, Canada, N6A5A5|
|Principal Investigator:||Neil Duggal, M.D., M.Sc.||Lawson Health Research Institute, London Health Sciences Center|