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

Primary Purpose

Deglutition Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Maintaining low (15mmHg) ETT cuff pressure
Maintaining a normal pressure in the ETT cuff
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deglutition Disorders focused on measuring Dysphagia, spine surgery, cuff pressure

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences Center, University Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Severity of dysphagia

Secondary Outcome Measures

Overall health score
Percentage change in anterior cervical soft-tissue thickness on plain lateral radiographs
Cost-effectiveness

Full Information

First Posted
May 31, 2006
Last Updated
August 25, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00332683
Brief Title
Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
Official Title
Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 6, 2006 (Actual)
Primary Completion Date
July 31, 2013 (Actual)
Study Completion Date
July 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deglutition Disorders
Keywords
Dysphagia, spine surgery, cuff pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients randomly assigned to this group will have no changes in the ETT during surgery
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients in this group will undergo same surgery as control group but with a monitoring and manipulation of ETT pressure
Intervention Type
Procedure
Intervention Name(s)
Maintaining low (15mmHg) ETT cuff pressure
Intervention Description
Manipulation of the ETT cuff pressure to hold a lower pressure of 15 mmHg
Intervention Type
Procedure
Intervention Name(s)
Maintaining a normal pressure in the ETT cuff
Intervention Description
No manipulation to maintain a low pressure of 15 mm Hg in the ETT cuff
Primary Outcome Measure Information:
Title
Severity of dysphagia
Time Frame
pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery
Secondary Outcome Measure Information:
Title
Overall health score
Time Frame
pre-operatively and at 24hrs, 6wks, 3mons and 6mons following surgery
Title
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
Title
Cost-effectiveness
Time Frame
6mons after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Duggal, M.D., M.Sc.
Organizational Affiliation
Lawson Health Research Institute, London Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center, University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
11074678
Citation
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.
Results Reference
background
PubMed Identifier
12435974
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. doi: 10.1097/00007632-200211150-00007.
Results Reference
background
PubMed Identifier
12394659
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. doi: 10.1097/00024720-200210000-00004.
Results Reference
background
PubMed Identifier
12296675
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. doi: 10.3171/spi.2002.97.2.0176.
Results Reference
background
PubMed Identifier
16284596
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. doi: 10.1097/01.brs.0000186317.86379.02.
Results Reference
background
PubMed Identifier
15223936
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. doi: 10.1097/01.brs.0000129100.59913.ea.
Results Reference
background
PubMed Identifier
8498671
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. doi: 10.1213/00000539-199376060-00023.
Results Reference
background
PubMed Identifier
10389801
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. doi: 10.1097/00000539-199907000-00033.
Results Reference
background
PubMed Identifier
14571336
Citation
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.
Results Reference
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Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure

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