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

NCT ID: NCT00332683

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-06
• Study Completion Date: 2013-07-31

Brief 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.

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.

Conditions

Deglutition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Patients randomly assigned to this group will have no changes in the ETT during surgery

Group Type: ACTIVE_COMPARATOR

Maintaining a normal pressure in the ETT cuff

Intervention Type: PROCEDURE

No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff

Treatment group

Patients in this group will undergo same surgery as control group but with a monitoring and manipulation of ETT pressure

Group Type: EXPERIMENTAL

Maintaining low (15mmHg) ETT cuff pressure

Intervention Type: PROCEDURE

Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg

Interventions

Maintaining low (15mmHg) ETT cuff pressure

Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg

Intervention Type: PROCEDURE

Maintaining a normal pressure in the ETT cuff

No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Duggal, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Lawson Health Research Institute, London Health Sciences Center

Locations

London Health Sciences Center, University Campus

London, Ontario, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 11074678 (View on PubMed)

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. doi: 10.1097/00007632-200211150-00007.

Reference Type: BACKGROUND

PMID: 12435974 (View on PubMed)

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. doi: 10.1097/00024720-200210000-00004.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 12296675 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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. doi: 10.1213/00000539-199376060-00023.

Reference Type: BACKGROUND

PMID: 8498671 (View on PubMed)

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. doi: 10.1097/00000539-199907000-00033.

Reference Type: BACKGROUND

PMID: 10389801 (View on PubMed)

Vanderveldt HS, Young MF. The evaluation of dysphagia after anterior cervical spine surgery: a case report. Dysphagia. 2003 Fall;18(4):301-4. doi: 10.1007/s00455-003-0012-z.

Reference Type: BACKGROUND

PMID: 14571336 (View on PubMed)

Other Identifiers

12338

Identifier Type: -

Identifier Source: secondary_id

R-06-225

Identifier Type: -

Identifier Source: org_study_id