Study: C-Collar and Dysphagia

• ClinicalTrials.gov Identifier: NCT03349125
• Recruitment Status: Completed
• First Posted: November 21, 2017
• Last Update Posted: October 2, 2019
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

Study Description

Brief Summary:

The purpose of this study is to characterize oral-pharyngeal swallow function with the guidance of videofluoroscopy under two conditions, with and without cervical bracing, in patients determined to have dysphagia.

Condition or disease	Intervention/treatment
Dysphagia	Behavioral: Collar On; Behavioral: Collar Off

Detailed Description:

According to the National Cervical Spinal Cord Injury Statistical Center, 12,000 patients experience acute spinal cord injury (SCI) in the United States annually. It is reported that 16% to 55% of patients with a cervical spinal cord injury (SCI) present with dysphagia which compromises their ability to eat and drink safely as well as their quality of life. Based on previous research, Dysphagia can also result in respiratory complications, particularly pneumonia, which is the most common cause of death in cervical SCI patients. The contribution of swallowing impairment, and associated aspiration risks, to respiratory illnesses and mortality in patients with SCI are unknown. As a first step, the investigators will identify the nature (type of swallowing impairment such as swallow delay, pharyngeal residue, penetration or aspiration) and frequency of occurrence of swallowing impairments in elderly patients with injury to the cervical spinal region. Further, the investigators will determine the effects of standard medical care, specifically, surgical bracing, on swallow function in patients post-cervical SCI.

Patients with SCI present with a range of impairments in the oral and pharyngeal phases of the swallow. These result both from the effects of trauma and medical/surgical management of injury on anatomy and physiology of the swallow mechanism. Earlier studies postulate that Acute SCI can result in reduced base of tongue movement, delayed pharyngeal swallow response, decreased hyolaryngeal excursion with subsequent decrease in cricopharyngeal opening, and pharyngeal wall dysfunction. These swallowing impairments are particularly devastating in older patients who lack the functional reserve to overcome these neuroanatomical insults. Consequently, there is an increased prevalence of dysphagia in the elderly patients with SCI.

Medical and surgical management of SCI can also negatively impact swallow function. Many patients will require neck immobilization following injury. Neck extension, chin or head retraction secondary to cervical bracing may increase the risk or severity of dysphagia by changing the mechanics of swallowing. In addition, fixation at a ninety-degree angle limits the natural flexion or range of movement a patient employs during deglutition. Studies have found that cervical orthoses impacts swallowing physiology in healthy adults. An earlier study reported changes in point of initiation of the swallow, laryngeal penetration, pharyngeal residue and hyoid bone movement. One would expect changes to be more significant in patients with dysphagia, and likely more remarkable in the elderly population who unfortunately, have the highest incidence of cervical SCI. Given the risk factors for dysphagia and pulmonary complications in this population, it is imperative that thorough evaluation of oral-pharyngeal swallow function be completed. However, there is little research addressing the impact of cervical bracing on patients with dysphagia at any age. The study team here aims to determine if cervical bracing contributes to severity of dysphagia.

Study Design

• Study Type: Observational
• Actual Enrollment: 23 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Effects of Cervical Bracing on Elderly Patients With Dysphagia
• Actual Study Start Date: September 17, 2013
• Actual Primary Completion Date: May 17, 2017
• Actual Study Completion Date: April 5, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Collar On; Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) on.	Behavioral: Collar On
Collar Off; Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) off.	Behavioral: Collar Off

Outcome Measures

Primary Outcome Measures :

1. To identify aspiration between study conditions (with and without a collar). [ Time Frame: Comparing aspiration presence between two study conditions (with and without a cervical collar). Data will be reported at the end of study completion, an average of 1 year. ]
   Measures of dysphagia aspiration (Y/N) and will be obtained in subjects both with and without a collar during the swallow evaluation.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Inpatients with dysphagia in a cervical brace.

Criteria

Inclusion Criteria:

1. Inpatients receiving treatment for a spine injury
2. Treating physician's approval that cervical cervical spinal column injury is stable
3. Approval for collar removal by treating physician during VFSS
4. Adults 60 and over.
5. All races.
6. Males and females.
7. Glasgow coma scale of 13 or greater.

Exclusion Criteria:

1. History of oral-pharyngeal dysphagia.
2. Neurologic disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
3. Pharyngeal/laryngeal surgery or head/neck radiation treatment.
4. Glasgow coma scale of less than 13 at time of evaluation.
5. Patient's with a tracheotomy.
6. Barium intolerance.
7. Patients who lack the capacity to consent on their own behalf

Contacts and Locations

Locations

United States, Wisconsin

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

• Principal Investigator: Jodi Hernandez, MS; University of Wisconsin, Madison

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03349125
• Other Study ID Numbers: 2017-0222; A539772 ( Other Identifier: UW Madison ); SMPH/SURGERY/SURGERY*SP ( Other Identifier: UW Madison )
• First Posted: November 21, 2017
• Last Update Posted: October 2, 2019
• Last Verified: October 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:

Cervical Brace; Elderly; Dysphagia; VFSS; Videoflouroscopy; Swallow Problems

Additional relevant MeSH terms:

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