ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dysphagia

Cervical Spine Injury

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

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]

Treatment: Devices

Intervention code [2]

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]

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]

Time of diagnosis of dysphagia

Secondary outcome [1]

Presence or absence of improvement of dysphagia and/or aspiration after orthosis adjustment.

Timepoint [1]

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?

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]

The Alfred - Prahran

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred hospital

Address [1]

55 Commercial Road
Melbourne 3004
Victoria

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Alfred Ethics committee

Ethics committee address [1]

Ground Floor, Linay Pavilion, The Alfred hospital
55 Commercial Road
Melbourne 3004
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2013

Approval date [1]

Ethics approval number [1]

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

Mr Patrick Chan

Address

Department of Neurosurgery, The Alfred hospital
Department of Neurosurgery, Level 1, Old Baker Building, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004

Country

Australia

Phone

+61390763716

Fax

p.chan@alfred.org.au

Contact person for public queries

Name

Philip Chan

Address

Department of Radiology, Level 1, Philip Block, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004

Country

Australia

Phone

+61390762000

Fax

philip.chan@alfred.org.au

Contact person for scientific queries

Name

Philip Chan

Address

Department of Radiology, Level 1, Philip Block, The Alfred hospital, Commercial Rd, Melbourne, Vic 3004

Country

Australia

Phone

+61390762000

Fax

philip.chan@alfred.org.au

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

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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