Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332683
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2006-05-31
Brief Title:
Reducing Dysphagia Associated With Anterior Cervical Spine Surgery by Maintaining Low Endotracheal Tube Cuff Pressure
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery A Prospective Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12338 | None | None | None |