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

NCT01209910 | Completed DMC

• 1 other identifier: 0120
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  one year

Study Arms (2)

free water

EXPERIMENTAL

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

Other: Water

Control

NO INTERVENTION

These subjects will be observed during the study.

Interventions

Water OTHER

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

Also known as: Drinking water

free water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Center

Winnipeg, Manitoba, R3L 2P4, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Water; Drinking Water

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sepideh Pooyania, MD. FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: September 27, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

CA (1)