CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Maintaining low (15mmHg) ETT cuff pressure +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00332683
NCT00332683N/ACompleted

Endotracheal Tube Cuff Pressure Protocol to Reduce Dysphagia Following Anterior Cervical Spine Surgery: A Prospective Randomized Pilot Study

In Brief

A clinical study evaluating Maintaining low (15mmHg) ETT cuff pressure and Maintaining a normal pressure in the ETT cuff for Deglutition Disorders. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2, 2006
Enrollment StartJun 6, 2006
Primary CompletionJul 31, 2013
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.1 years ago

Interventions

Maintaining low (15mmHg) ETT cuff pressureprocedure

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

Maintaining a normal pressure in the ETT cuffprocedure

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