The Frazier free water protocol (FWP), developed by the Frazier Rehabilitation Institute (Panther, 2005), is an option available as part of dysphagia rehabilitation that allows patients with dysphagia who are on diet restrictions that include thickened liquids to also have regular water as part of their diet. Patients follow specific guidelines to decrease the risk of developing aspiration pneumonia while continuing oral intake of water, even with their diet restrictions calling for use of thickened liquids. Many hospital patients who have a restricted diet that includes use of thickened liquids have additional medical issues, including malnutrition, dehydration, and xerostomia. These medical issues can lead to complications including renal dysfunction, electrolyte disturbance, poor wound healing, infections, confusion, weakness, constipation, failure to thrive, and reduction in quality of life (Panther, 2005). At this time, limited information is available regarding use of the FWP with hospitalized patients who have dysphagia and compromised pulmonary status.

The objective of this study was to increase knowledge of the risk of developing aspiration pneumonia if water or ice chips are taken by patients who are pulmonary compromised, have dysphagia, and require use of thickened liquids. The specific aim of this study was to determine whether use of water or ice chips under specific guidelines alters the risk of developing aspiration pneumonia in hospitalized, pulmonary-compromised patients. The types of patients who would benefit from this intervention are medically complex, critical illness survivors who have dysphagia. There is a critical need for clinicians to be aware of the risks and benefits of a free water protocol as an option to improve quality of life for patients who have dysphagia.

Dysphagia is characterized by abnormality in the transfer of a food or liquid bolus from the mouth to the stomach (Groher, 1997). Crary and Groher (2003)  noted that dysphagia is commonly observed in hospital settings. Among intensive care unit patients, dysphagia affects an estimated 20% of survivors of respiratory failure who require endotracheal intubation and is associated with increased hospital length of stay, morbidity, and mortality (Macht et al., 2011; Skoretz, Flowers, & Martino, 2010). Aspiration pneumonia occurs when organisms infiltrate the lower respiratory tract during an episode of aspiration and the patient is unable to clear the material, creating pulmonary complications (Groves-Wright, 2003).

Dysphagia requires formal evaluation and treatment by members of the rehabilitation team. Skoretz et al. (2010)  and Macht et al. (2011)  recommended a formal dysphagia evaluation for patients recovering from critical illness, especially if intubation was prolonged. Occupational therapists who are dysphagia trained can be valued members of the dysphagia evaluation team because of their unique skills in evaluating swallowing disorders and related feeding activities and in recommending adaptive equipment that can promote independence in feeding.

The FWP is a tool used by dysphagia therapists that allows patients with dysphagia to ingest water between meals. Water has been thought to be a benign substance in the lungs because of its neutral pH (Franceschini, 2007). For this reason, water has been hypothesized to be safe for people on a thickened liquid diet. A 2012 study by Carlaw et al. examined a trial implementation of a water protocol in 15 participants and demonstrated that they remained free from pneumonia over the course of an initial 14-day trial and continuing until dismissal from the facility (range = 13–108 days). The participants in this study had diagnoses of acquired brain injury, neuromusculoskeletal injury, or spinal cord injury. A study by Garon, Engle, and Ormiston (1997)  followed patients on a modified diet for approximately 1 mo. The patients were allowed to drink water and did not subsequently develop aspiration pneumonia, dehydration, or other related complications.

The original emphasis of the FWP may have been to increase compliance of modified diets; however, more recently, researchers have considered whether the FWP can assist in the prevention of dehydration. Panther (2005)  reported that patients for whom free water protocols were implemented had fewer complaints about thirst and increased compliance with a thickened liquid diet. Marik and Kaplan (2003)  noted that dehydration is one of the leading problems among older adults in long-term care facilities. They concluded that potential patient outcomes with regard to the FWP can include compliance with dietary modifications, fewer complications from dehydration, increased patient satisfaction, and no significant development of aspiration pneumonia.

Although adequate information is available regarding use of the FWP in patients who are medically stable, tolerate moderate activity levels, are cognitively intact, and are able to participate in good oral care and comply with the FWP, evidence using the FWP with patients who have pulmonary compromise and concomitant dysphagia within a hospital setting is limited. The pilot study described in this article increases our knowledge base about use of the FWP for patients with compromised pulmonary status and its association with developing aspiration pneumonia.

The research design was a two-group nonequivalent comparison group design. All adult (>18 yr) patients admitted to the nine-bed respiratory care unit (RCU) at Mayo Clinic Hospital–Rochester, Saint Marys Campus, were evaluated for candidacy. Compromised pulmonary status was inherent in the RCU admission population; all patients were critical illness survivors requiring tracheostomy with mechanical ventilation, noninvasive bilevel pressure ventilation, or high-flow oxygen. Additional study inclusion criteria included dysphagia concerns, an occupational therapy recommendation to follow a modified diet that included thickened liquids, and the ability to follow the specific free water guidelines. Excluded from the study were outpatients, patients with no dysphagia concerns, patients not on the RCU, and patients not requiring thickened liquids.

The focus of this pilot study was to implement a modified version of the FWP (Figure 1) on the RCU and to consider the free water guidelines as the standard of care with close monitoring of any signs of worsening pulmonary status. Because of the complexity of the patients’ diagnoses, a more conservative approach of the FWP was used, with the only difference from the original FWP being that the patients were offered ice chips or sips of water freely, rather than just sips of water. Between June 2009 and April 2011, 369 patients were admitted to the RCU. Of the admissions, 354 were excluded, leaving 15 patients who met the inclusion criteria.

Once a patient was deemed clinically appropriate, the health care team requested dysphagia evaluation; 15 patients were found to require thickened liquids. These patients were provided with information about the free water guidelines and the RCU standard of care with regard to using ice chips or sips of water, and they then provided consent for the FWP study. Consistent with the free water guidelines, patients were allowed sips of water or ice chips between meals, with fastidious oral care 3 to 5 times daily. Repeat dysphagia evaluations were conducted approximately 2 wk after each initial dysphagia evaluation. Throughout the pilot study, health care team members closely monitored each participant for development of aspiration pneumonia.

Implementation of the pilot study included instructional sessions and demonstration of the free water guidelines for the nursing staff. The free water guidelines for implementation were posted in the patients’ rooms, and a water pitcher symbol was used to designate whether the patient was on the free water study. During the pilot phase, the nursing staff were receptive to and compliant with the instructions and education regarding the free water guidelines. Patients were followed by an RCU physician on a daily basis during medical rounds.

The 15 control participants were chosen from a retrospective chart review of consecutive RCU admissions that met the same inclusion and exclusion criteria. All pertinent patient information was gathered from their medical charts (Table 1). Data collected included diagnosis, initial respiratory status at the time of the dysphagia evaluation, chest X rays, date and results of initial clinical dysphagia evaluation, videofluoroscopy and any repeat videofluoroscopies, diet groups recommended and tolerated, any alternative methods of nutrition needed and used, clinical documentation of pneumonia, worsening of medical issues, transfers to intensive care units, and any deaths.

The institutional review board at the setting approved the study before implementation. Participation in the study was voluntary, and participants provided informed consent. Patient confidentiality was ensured through use of a coding system to replace patient identifiers. All information throughout the study was recorded by the investigators and manually entered into a secure, password-protected electronic database.

The 15 intervention participants’ primary diagnosis included respiratory failure (n = 4); cardiothoracic surgery (n = 3); neuromuscular disease (n = 2); and esophageal cancer, abdominal pain, total knee arthrosis infection, pneumonia, pancreatitis, and apical ballooning (n = 1 each; Table 2). Six participants had had a secondary diagnosis of pneumonia, and 14 had had a tracheostomy during the current hospital episode.

Fourteen participants were initially evaluated with a bedside clinical dysphagia evaluation. The clinical dysphagia evaluation is the standard of care before making recommendations for diet modifications. The increased complex status of 1 participant required formal evaluation with videofluoroscopy upon receiving consult. Seven participants were further evaluated with a formal videofluoroscopic swallow study. Seven participants (47%) required use of nectar liquids, 4 (27%) required use of honey-thick liquids, 3 (20%) required use of pudding-thick liquids, and 1 (7%) was not safe for any oral intake. Repeat videofluoroscopies were performed with 12 participants.

During the study, 14 (93%) participants’ diets advanced from thickened liquids, and only 1 (7%) had diet regression during repeat dysphagia evaluations (Figure 2). During participants’ RCU stay, 6 (40%) were readmitted to the intensive care unit. One participant was diagnosed with clinical pneumonia; this patient had esophageal cancer and was later diagnosed with tracheoesophageal fistula, which likely contributed to the pneumonia. Intervention participants did not differ significantly from the control group in the rate of aspiration pneumonia, χ²(30) = .01, p = 1.00. Regarding hospital discharge disposition, 1 (7%) intervention participant was discharged home, 1 (7%) was deceased, 4 (27%) entered a rehabilitation unit, 3 (20%) entered a long-term acute care hospital, and 6 (40%) entered a skilled nursing facility.

This study has some limitations. The small sample size and single institution may limit the generalizability of the results. No formal measure of the amount of ice chips or water was used, and no formal measure of dehydration in participants was completed. Although quality of life is crucial in the care of this population, no quality of life measure was completed. Previous evidence from the original version of the FWP suggests that modified diets that require use of thickened liquids only deny patients with dysphagia the basic desire to be revitalized by a sip of water. More recently, Karagiannis and Karagiannis (2014)  stated that it is clearly evident that there is an increase in the quality of life of patients with dysphagia who are allowed access to water.

The control group was from a retrospective gathering and the intervention group from a prospective gathering. There was no way to ensure that the data recording quality was equivalent between the groups. The retrospective control group used in this pilot study may have provided a weaker comparison than a prospective control group; the relationship between the development of aspiration pneumonia and use of the free water guidelines in both groups was low. To refine the research, a future study that includes a prospective control group may be beneficial.

The results of this study have the following implications for occupational therapy practice:

• Patients who experience dysphagia and pulmonary compromise after critical illness can have ice chips or sips of water when on a modified diet with no change in risk of developing pneumonia.

• The literature provides evidence to support increased compliance with modified diet recommendations and decreased risk of dehydration when free water guidelines are used.

• This study supports the use of free water guidelines as an evidence-based intervention for critical illness survivors who have pulmonary compromise.

Intake of ice chips or water according to a modified FWP by patients with dysphagia and compromised pulmonary status did not increase the incidence of aspiration pneumonia compared with a control group that did not receive the intervention. This pilot study serves as an initial investigation in providing an evidence base for medical professionals considering the use of the FWP for patients with dysphagia and pulmonary compromise. This preliminary information supports the use of free water guidelines to increase critical illness survivors’ compliance with a modified dysphagia diet and decrease their risk for dehydration. Further research is needed on the contribution of this intervention to quality of life with minimal risk for survivors of critical illness during their recovery.