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

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Water
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dysphagia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riverview Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

free water

Control

Arm Description

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

These subjects will be observed during the study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

to expand the study to a multi-centre clinical trial.
to expand the study to a multi-centre clinical trial.

Full Information

First Posted
July 13, 2010
Last Updated
August 6, 2013
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT01209910
Brief Title
Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting
Official Title
Effects of Free Water Protocol on Inpatients in a Neurological Rehabilitation Setting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
free water
Arm Type
Experimental
Arm Description
The subjects in this arm will be able to drink water followings study rules.
Arm Title
Control
Arm Type
No Intervention
Arm Description
These subjects will be observed during the study.
Intervention Type
Other
Intervention Name(s)
Water
Other Intervention Name(s)
Drinking water
Intervention Description
Subjects in this arm will be able to drink water with some conditions.
Primary Outcome Measure Information:
Title
Outcome measures will include the rate of aspiration pneumonia, quality of life related to swallowing, fluid intake, and hydration level
Description
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
Secondary Outcome Measure Information:
Title
to expand the study to a multi-centre clinical trial.
Description
to expand the study to a multi-centre clinical trial.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sepideh Pooyania, MD. FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riverview Health Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada

12. IPD Sharing Statement

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

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