Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting
|ClinicalTrials.gov Identifier: NCT01209910|
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : August 9, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Other: Water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||March 2013|
Experimental: free water
The subjects in this arm will be able to drink water followings study rules.
Subjects in this arm will be able to drink water with some conditions.
Other Name: Drinking water
No Intervention: Control
These subjects will be observed during the study.
- Outcome measures will include the rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration level [ Time Frame: While admitted in hospital, or develop a complication up to 12 months ]Outcome measures will include the rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration level
- to expand the study to a multi-centre clinical trial. [ Time Frame: one year ]to expand the study to a multi-centre clinical trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209910
|Riverview Health Center|
|Winnipeg, Manitoba, Canada, R3L 2P4|
|Principal Investigator:||Sepideh Pooyania, MD. FRCPC||University of Manitoba|