Deglutition Disorders | Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
Deglutition Disorders research study
What is the primary objective of this 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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Maintaining low (15mmHg) ETT cuff pressureManipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
Procedure:Maintaining a normal pressure in the ETT cuffNo manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
ControlPatients randomly assigned to this group will have no changes in the ETT during surgery
Treatment groupPatients in this group will undergo same surgery as control group but with a monitoring and manipulation of ETT pressure
Start Date: June 6, 2006
Completed Date: July 31, 2013
Primary Outcome: Severity of dysphagia
Secondary Outcome: Overall health score
Study sponsors, principal investigator, and references
Principal Investigator: Neil Duggal, M.D., M.Sc.
Lead Sponsor: Lawson Health Research Institute
Apfelbaum RI, Kriskovich MD, Haller JR. On the incidence, cause, and prevention of recurrent laryngeal nerve palsies during anterior cervical spine surgery. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2906-12.