Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects

The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the US among persons age 65 years and over. Current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. This is a Phase III inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. This study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.

Inclusion Criteria: Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows. Exclusion Criteria: Have smoked more than a pack of cigarettes per day in the last year. Drink more than 3 alcoholic beverages per day on a regular basis. Have had any head and neck cancer treatment. Have any head and neck anatomic deformities. Have a history of 20 years or longer of insulin-dependent diabetes. Have other exclusionary neurologic diagnoses. Have had pneumonia within 6 weeks of screening. Currently have a nasogastric tube. Currently have a tracheotomy. Are a resident in non-participating nursing home or assisted living environment. Live alone. Have no regular care provider present at meals. Have no Speech-Language Pathologist to provide a 3-month follow-up.

Robbins J, Gensler G, Hind J, Logemann JA, Lindblad AS, Brandt D, Baum H, Lilienfeld D, Kosek S, Lundy D, Dikeman K, Kazandjian M, Gramigna GD, McGarvey-Toler S, Miller Gardner PJ. Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial. Ann Intern Med. 2008 Apr 1;148(7):509-18. doi: 10.7326/0003-4819-148-7-200804010-00007. Erratum In: Ann Intern Med. 2008 May 6;148(9):715.