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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00332683
First received: May 31, 2006
Last updated: June 2, 2010
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Deglutition Disorders
 Procedure: Maintaining low (15mmHg) ETT cuff pressure
Procedure: Maintaining a normal pressure in the ETT cuff

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Severity of dysphagia [ Time Frame: pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall health score [ Time Frame: pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 6mons after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332683

Contacts
Contact: Izabela Kowalczyk, BHSc 519-685-8500 ext 35456 ikowalcz@uwo.ca
Contact: Jennifer Moore 519-685-8500 ext 32926 jennifer.moore@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Center, University Campus Recruiting
London, Ontario, Canada, N6A5A5
Contact: Izabela Kowalczyk, BHSc     519-685-8500 ext 35456     ikowalcz@uwo.ca    
Contact: Jennifer Moore     519-685-8500 ext 32926     jennifer.moore@lhsc.on.ca    
Principal Investigator: Neil Duggal, M.D., M.Sc.            
Sub-Investigator: Miguel Arango, M.D.            
Sub-Investigator: Doron Rabin, M.D.            
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Neil Duggal, M.D., M.Sc. Lawson Health Research Institute, London Health Sciences Center
  More Information

Publications:

Responsible Party: Neil Duggal, MSc, MD, FRCS(C), London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00332683     History of Changes
Other Study ID Numbers: R-06-225, 12338
Study First Received: May 31, 2006
Last Updated: June 2, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Dysphagia
spine surgery
cuff pressure

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013