None listed
Conditions
Brief summary
The research project is aimed to determine whether Halo-thoracic orthosis fixation (Halo brace) contributes to dysphagia (swallowing dysfunction), which put patients at risk of aspiration (contents of the oral cavity entering the airway) and ultimately pneumonia (chest infection). Using fluoroscopy (special x-ray test), patients with dysphagia will be identified and repositioned in the Halo-thoracic orthosis so that the risk of aspiration and pneumonia is less. First, it determines how many patients have dysphagia when placed into a Halo-thoracic orthosis. These patients are at risk of aspirating, which can cause a life-threatening pneumonia. If patients are found to have dysphagia, determined by bedside testing and fluoroscopy, they will have the Halo-thoracic orthosis re-adjusted so that dysphagia may be alleviated, removing the potential risk of aspiration and pneumonia. This has the potential to benefit a large number of patients in identifying and treating dysphagia which previously may have gone undiagnosed. There is very little literature worldwide on this subject, and the studies so far have a relatively small number of participants. What is known is that being fixated in a Halo-thoracic orthosis can cause dysphagia, and the true extent of the problem is probably underestimated in these patients, particularly the elderly. By exploring this subject, this project will contribute significantly to the limited worldwide literature. An estimated 200 participants will be taking part in the study at The Alfred hospital, over a proposed period of two years. This research is conducted by the principal investigators, Mr Patrick Chan, consultant Neurosurgeon, Dr Philip Chan, radiological registrar, at The Alfred hospital, and Dr Amanda Scott, speech pathology, at The Alfred hospital, in collaboration with Professor Mark Fitzgerald in the Department of Trauma Surgery, along with other heads of department in Orthopaedic Surgery, Radiology, and Orthotics. There are no external organisations involved, and all research is to be conducted within and funded by Alfred Health (Department of Trauma Surgery).
Interventions
Adjustment of Halo-Thoracic Brace performed by hospital orthotist
This is performed as how an orthotist would routinely adjust a malfitted Halo-Thoracic Brace, which would include pin retensioning whilst the spine (orthopaedic or neurosurgical) registrar manually stabilises the patient's head. Adjustment typically takes 15-30 minutes, and is performed after the initial video fluoroscopy if there is significant dysphagia or aspiration. This is only maximally attempted once.
Video fluoroscopy is t
Adjustment of Halo-Thoracic Brace performed by hospital orthotist This is performed as how an orthotist would routinely adjust a malfitted Halo-Thoracic Brace, which would include pin retensioning whilst the spine (orthopaedic or neurosurgical) registrar manually stabilises the patient's head. Adjustment typically takes 15-30 minutes, and is performed after the initial video fluoroscopy if there is significant dysphagia or aspiration. This is only maximally attempted once. Video fluoroscopy is the radiological method of diagnosing dysphagia or aspiration. All patients will undergo a clinical bedside assessment by a speech pathologist. Video fluoroscopy assessment will be performed as per hospital protocol, which involves swallowing of varied consistency barium-laced liquid/puree/food and the swallowing process is visualised under fluoroscopy. It is a 15-30 minute procedure. To summarise: 1. All patients fitted Halo are included into the study. 2. All patients are screened by the bedside by a speech pathologist. 3. All patients undergo a videofluoroscopic swallowing assessment (15-30 minutes). 4A. Patients without dysphagia or aspiration will not undergo further treatment or adjustment. They will attend routine follow up. 4B. Patients identified with dysphagia or aspiration will have ONE (maximum) attempt at Halo-Thoracic orthosis adjustment (15-30 minutes) immediately in the fluoroscopy suite. Immediately post adjustment, they will undergo ONE (maximum) more videofluoroscopy (15-30 minutes) to see if dysphagia or aspiration is resolved.
Sponsors
Department of Trauma Services, The Alfred hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 or above (ie => 18 years), male or female; Patients admitted for cervical spinal injury requiring Halo-Thoracic orthosis; Patients under the care of Orthopaedic or Neurosurgical spinal teams; and Informed consent obtained.
Exclusion criteria
Age less than 18 years (ie < 18 years); Patients who have pre-exisiting medical co-morbidities complicated by dysfunctional swallow (ie progressive neurological disorders, achalasia or pre-existing dysmotility); Patients with medical co-morbidities limiting feasibility and safety of videofluoroscopy; Tracheostomised patients; Uncooperative patients; and Patients not consenting to participate in the study.
Outcome results
None listed