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

NCT00332683 | Completed

• 2 other identifiers: R-06-22512338
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Deglutition Disorders

Keywords

Dysphagia; spine surgery; cuff pressure

Outcome Measures

Primary Outcomes (1)

• Severity of dysphagia

  pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery

Secondary Outcomes (3)

• Overall health score

  pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery

• Percentage change in anterior cervical soft-tissue thickness on plain lateral radiographs

  pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery

• Cost-effectiveness

  6mons after surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Maintaining a normal pressure in the ETT cuff

Treatment group

EXPERIMENTAL

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

Interventions

Maintaining low (15mmHg) ETT cuff pressure PROCEDURE

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

Treatment group

Maintaining a normal pressure in the ETT cuff PROCEDURE

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

Control

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Center, University Campus

London, Ontario, N6A5A5, Canada

Location

Related 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. doi: 10.1097/00007632-200011150-00012.

  PMID: 11074678 BACKGROUND

• 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.

  PMID: 12435974 BACKGROUND

• 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.

  PMID: 12394659 BACKGROUND

• 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. doi: 10.3171/spi.2002.97.2.0176.

  PMID: 12296675 BACKGROUND

• 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. doi: 10.1097/01.brs.0000186317.86379.02.

  PMID: 16284596 BACKGROUND

• 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. doi: 10.1097/01.brs.0000129100.59913.ea.

  PMID: 15223936 BACKGROUND

• 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.

  PMID: 8498671 BACKGROUND

• 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.

  PMID: 10389801 BACKGROUND

• 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.

  PMID: 14571336 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Neil Duggal, M.D., M.Sc.

  Lawson Health Research Institute, London Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 2, 2006
• Study Start: June 6, 2006
• Primary Completion: July 31, 2013
• Study Completion: July 31, 2013
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)