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Trial registered on ANZCTR


Registration number
ACTRN12614000254695
Ethics application status
Not yet submitted
Date submitted
12/02/2014
Date registered
10/03/2014
Date last updated
10/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Incidence and treatment of Clinically Significant Swallowing Dysfunction in Patients Treated in Halo-thoracic Brace for Cervical Spine Injury.
Scientific title
Incidence and Treatment of Clinically Significant Dysphagia amongst Patients Treated in Halo-Thoracic Orthoses for Cervical Spine Injury.
Secondary ID [1] 284084 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 291152 0
Cervical Spine Injury 291153 0
Condition category
Condition code
Oral and Gastrointestinal 291489 291489 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 291490 291490 0 0
Other muscular and skeletal disorders
Injuries and Accidents 291615 291615 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288777 0
Treatment: Devices
Intervention code [2] 288913 0
Diagnosis / Prognosis
Comparator / control treatment
Patients will be acting as their own control – ie prior to readjustment of Halo-Thoracic orthosis vs post adjustment of Halo-Thoracic orthosis
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291465 0
Diagnosis of dysphagia and/or aspiration; and
Need of Halo-Thoracic orthosis adjustment.

Diagnosis of dysphagia or aspiration is performed by bedside assessment by speech pathologist, and also by videofluorscopic assessment (see earlier entry for details of this radiological examination).
Once the diagnosis of dysphagia or aspiration is confirmed on fluoroscopy, the decision is made, based on the level of dysphagia/aspiration and the current clinical scenario, by the spinal team whether there is a need for orthotic adjustment.
Timepoint [1] 291465 0
Time of diagnosis of dysphagia
Secondary outcome [1] 306835 0
Presence or absence of improvement of dysphagia and/or aspiration after orthosis adjustment.
Timepoint [1] 306835 0
After orthosis adjustment on videofluoroscopy.

If orthotic adjustment is required (within the fluoroscopy suite), a repeat videofluoroscopy will be performed immediately post adjustment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants are selected for further intervention if there is a clinical indication for further treatment (ie clinically significant dysphagia)
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2080 0
The Alfred - Prahran

Funding & Sponsors
Funding source category [1] 288714 0
Hospital
Name [1] 288714 0
The Alfred hospital
Country [1] 288714 0
Australia
Primary sponsor type
Hospital
Name
Department of Trauma Services, The Alfred hospital
Address
55 Commercial Road
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 287416 0
None
Name [1] 287416 0
N/A
Address [1] 287416 0
N/A
Country [1] 287416 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290550 0
The Alfred Ethics committee
Ethics committee address [1] 290550 0
Ground Floor, Linay Pavilion, The Alfred hospital
55 Commercial Road
Melbourne 3004
Victoria
Ethics committee country [1] 290550 0
Australia
Date submitted for ethics approval [1] 290550 0
19/11/2013
Approval date [1] 290550 0
Ethics approval number [1] 290550 0
508/13

Summary
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).
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 46218 0
Mr Patrick Chan
Address 46218 0
Department of Neurosurgery, The Alfred hospital
Department of Neurosurgery, Level 1, Old Baker Building, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004
Country 46218 0
Australia
Phone 46218 0
+61390763716
Fax 46218 0
Email 46218 0
[email protected]
Contact person for public queries
Name 46219 0
Philip Chan
Address 46219 0
Department of Radiology, Level 1, Philip Block, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004
Country 46219 0
Australia
Phone 46219 0
+61390762000
Fax 46219 0
Email 46219 0
[email protected]
Contact person for scientific queries
Name 46220 0
Philip Chan
Address 46220 0
Department of Radiology, Level 1, Philip Block, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004
Country 46220 0
Australia
Phone 46220 0
+61390762000
Fax 46220 0
Email 46220 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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