A Study of Swallowing Problems and Aspiration Risks in Elderly Patients with Cervical Spine Fractures
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006268
Sponsor Protocol Number: 15-006268
About this study
The purpose of this study is to determine the incidence of swallowing disorders and the risk for aspiration in elderly patients who have cervical spine fractures.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Above 65 years of age
- Controls undergoing elective lumbar spine surgery within Mayo Clinic Rochester
- Patients with a stable cervical spine fracture and have a collar
- Treated either operatively or non-operatively, and sent to the ICU
- Have an initial video swallow test done in either the Speech Language Pathology or Occupational Therapy Units
Exclusion Criteria
- Had a preexisting swallowing disorder, including ENT malignancy or previous ENT surgery
- Neurological disorder such as Parkinson’s disease
- Without a cervical brace
- Has maxillofacial trauma or head trauma
- Peptic stricture
- Eosinophilic esophagitis
- Esophageal webs and rings
- Carcinoma of the lung, esophagus, or ENT
- Cardiovascular anomalies
- Radiation injury
- Achalasia
- Spastic motility disorders
- Scleroderma
- Sjögren's syndrome
- Functional dysphagia
- Pathological or infection related cervical spine fracture
- Below 65 years of age
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Michelle Clarke, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available