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

NCT00332683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-08-28

No results posted yet for this study

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

Interventions

PROCEDURE

Maintaining low (15mmHg) ETT cuff pressure

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

PROCEDURE

Maintaining a normal pressure in the ETT cuff

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Neil Duggal, M.D., M.Sc. · Lawson Health Research Institute, London Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-06
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00332683 on ClinicalTrials.gov