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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209910
• Other study ID #: 0120
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: August 6, 2013
• Start date: August 2010
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dysphagia

Intervention

Other:
• Water
Subjects in this arm will be able to drink water with some conditions.

Locations

Country	Name	City	State
Canada	Riverview Health Center	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

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