Dysphagia Clinical Trial
Official title:
Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting
Verified date | August 2013 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Inpatients in the neurology rehabilitation units at Riverview Health Center― people who are
brain-injured and or who have had a stroke ― often have dysphagia as a result of their
condition. They are considered at high risk of aspiration, which can result in pneumonia. To
limit that risk, these patients are only allowed to consume thickened liquids at the
beginning of their rehabilitation. They are restricted from consuming thin liquids, which
means they can't even drink water. Depending on the rate of their rehabilitation, these
restrictions can last from six months to a year.
Patients on a diet of thickened liquids sometimes have difficulty consuming the required
daily intake of fluids and they become dehydrated, which in turn can lead to other health
complications. As well, thickened liquids do not always satisfy a patient's thirst, says
Pooyania.
While Riverview does not allow inpatients with dyspagia to have water at the beginning of
their rehabilitation, many rehab facilities in Canada and the U.S. follow the "Frazier Free
Water Protocol," which does allow patients unrestricted water intake prior to and 30 minutes
after meals. The belief that this protocol is safe is based on research done at the Frazier
Rehabilitation Institute, where a study demonstrated no difference in rates of aspiration
pneumonia between an experimental group on a free water protocol and a control group.
The Frazer study was only one randomized controlled trial with a very limited number of
patients. There have been a few case reports as well, but at Riverview centre, the protocol
is not accepted because the investigators don't believe there is enough evidence behind it.
The investigators intend to provide more clinical evidence so that both the risks and
benefits of a free water protocol can be assessed.
The investigators will be screening patients admitted to the neurology rehabilitation units
at RCH, including both the stroke and acquired brain injury programs. The investigators
expect to find at least 30 suitable candidates.
Participants will be educated about dysphagia and the free water protocol, and the treatment
group will be allowed unrestricted water intake prior to and 30 minutes after meals.
Individualized intervention to minimize aspiration will be provided. Daily and weekly
monitoring and testing of all patients will take place. The pilot study will continue for 11
months. A secondary objective of the research is to determine the feasibility of expanding
into a multi-centre clinical trial
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients admitted with thin fluid restriction to the Stroke and Acquired Brain Injury Units at Riverview Health Centre for the duration of the study will be considered for eligibility. Exclusion Criteria: - Exclusion criteria include the following: history of severe pulmonary complications, individuals demonstrating severe coughing to the point of discomfort or medical complications when consuming thin fluids, individuals with immune deficiency problems or severe cognitive impairment that would affect patient's ability to sign the consent form or follow the protocol. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | Riverview Health Center | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Outcome measures will include the rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration level | Outcome measures will include the rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration level | While admitted in hospital, or develop a complication up to 12 months | Yes |
Secondary | to expand the study to a multi-centre clinical trial. | to expand the study to a multi-centre clinical trial. | one year | Yes |
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