Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
Recruitment status was: Recruiting
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.
|Deglutition Disorders||Procedure: Maintaining low (15mmHg) ETT cuff pressure Procedure: Maintaining a normal pressure in the ETT cuff|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study|
- 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 ]
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332683
|Contact: Izabela Kowalczyk, BHSc||519-685-8500 ext firstname.lastname@example.org|
|Contact: Jennifer Moore||519-685-8500 ext email@example.com|
|London Health Sciences Center, University Campus||Recruiting|
|London, Ontario, Canada, N6A5A5|
|Contact: Izabela Kowalczyk, BHSc 519-685-8500 ext 35456 firstname.lastname@example.org|
|Contact: Jennifer Moore 519-685-8500 ext 32926 email@example.com|
|Principal Investigator: Neil Duggal, M.D., M.Sc.|
|Sub-Investigator: Miguel Arango, M.D.|
|Sub-Investigator: Doron Rabin, M.D.|
|Principal Investigator:||Neil Duggal, M.D., M.Sc.||Lawson Health Research Institute, London Health Sciences Center|