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

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332683
• Other study ID #: R-06-225
• Secondary ID: 12338
• Status: Completed
• Phase: N/A
• First received: May 31, 2006
• Last updated: August 25, 2017
• Start date: June 6, 2006
• Est. completion date: July 31, 2013

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 31, 2013
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Procedure:
• Maintaining low (15mmHg) ETT cuff pressure
Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
• Maintaining a normal pressure in the ETT cuff
No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff

Locations

Country	Name	City	State
Canada	London Health Sciences Center, University Campus	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

Bazaz R, Lee MJ, Yoo JU. Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine (Phila Pa 1976). 2002 Nov 15;27(22):2453-8. — View Citation

Frempong-Boadu A, Houten JK, Osborn B, Opulencia J, Kells L, Guida DD, Le Roux PD. Swallowing and speech dysfunction in patients undergoing anterior cervical discectomy and fusion: a prospective, objective preoperative and postoperative assessment. J Spinal Disord Tech. 2002 Oct;15(5):362-8. — View Citation

Ratnaraj J, Todorov A, McHugh T, Cheng MA, Lauryssen C. Effects of decreasing endotracheal tube cuff pressures during neck retraction for anterior cervical spine surgery. J Neurosurg. 2002 Sep;97(2 Suppl):176-9. — View Citation

Riley LH 3rd, Skolasky RL, Albert TJ, Vaccaro AR, Heller JG. Dysphagia after anterior cervical decompression and fusion: prevalence and risk factors from a longitudinal cohort study. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2564-9. — View Citation

Smith-Hammond CA, New KC, Pietrobon R, Curtis DJ, Scharver CH, Turner DA. Prospective analysis of incidence and risk factors of dysphagia in spine surgery patients: comparison of anterior cervical, posterior cervical, and lumbar procedures. Spine (Phila Pa 1976). 2004 Jul 1;29(13):1441-6. — View Citation

Sperry RJ, Johnson JO, Apfelbaum RI. Endotracheal tube cuff pressure increases significantly during anterior cervical fusion with the Caspar instrumentation system. Anesth Analg. 1993 Jun;76(6):1318-21. — View Citation

Tu HN, Saidi N, Leiutaud T, Bensaid S, Menival V, Duvaldestin P. Nitrous oxide increases endotracheal cuff pressure and the incidence of tracheal lesions in anesthetized patients. Anesth Analg. 1999 Jul;89(1):187-90. — View Citation

Vanderveldt HS, Young MF. The evaluation of dysphagia after anterior cervical spine surgery: a case report. Dysphagia. 2003 Fall;18(4):301-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of dysphagia		pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery
Secondary	Overall health score		pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery
Secondary	Percentage change in anterior cervical soft-tissue thickness on plain lateral radiographs		pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery
Secondary	Cost-effectiveness		6mons after surgery