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Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting

NCT ID: NCT01209910

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-03-31

Brief Summary

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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

Detailed Description

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Research to determine the impact of a free water protocol on inpatients in a neurological rehabilitation setting is extremely relevant to the patient population at Riverview Health Centre (RHC), as many patients at RHC receive a modified diet consisting of thickened liquids. To date, the research base for the use of free water protocols is limited. Despite the general lack of research evidence, modified versions of a free water protocol have been adopted at numerous facilities across North America. Pursuing clinical research to measure the effects of a free water protocol on rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration levels, would provide research evidence to help guide patient care. If such research were to show that a free water protocol could be used without increased risk to patients with dysphagia, the patient population at Riverview, and at other rehabilitation centers, could benefit.

Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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free water

The subjects in this arm will be able to drink water followings study rules.

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

Subjects in this arm will be able to drink water with some conditions.

Control

These subjects will be observed during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Water

Subjects in this arm will be able to drink water with some conditions.

Intervention Type OTHER

Other Intervention Names

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Drinking water

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Dr. S. Pooyani

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sepideh Pooyania, MD. FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Riverview Health Center

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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0120

Identifier Type: -

Identifier Source: org_study_id