Drug to Prevent Pneumonia in the Tube Fed
Drug to Prevent Pneumonia in the Tube Fed
Background: Older people with neurological dysphagia are at risk of recurrent aspiration
 pneumonia. Angiotensin converting enzyme inhibitor (ACEI) has been shown to improve
 swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia.

 Hypotheses: ACEI reduces the risk of pneumonia in older patients who are nasogastric tube fed
 because of dysphagia from cerebrovascular diseases.

 Design: Randomized placebo controlled trial

 Method: 302 older patients who have been tube fed for more than two weeks because of
 dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5
 mg or placebo tablet once daily for 26 weeks. The subjects will be recruited from medical
 wards in Prince of Wales and Shatin Hospitals, and from outpatients of geriatric or speech
 therapy clinics, who have had hospital stay in previous three months. The subjects are
 followed up at week 12 and 26. The primary outcome is the incidence rate of pneumonia as
 determined by pneumonic change on X ray and clinical criteria. The secondary outcomes are
 mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by
 the Royal Brisbane Hospital Outcome Measure at week 12. Cost effectiveness analysis of public
 health care and personal health care costs will be performed. Intention to treat and log rank
 will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial
 group) recruited from medical inpatients at Prince of Wales Hospital will undergo swallowing
 videofluoscopy at baseline and week 12 follow-up.
Inclusion Criteria:

 -  Tube fed for more than four weeks for reason of neurological dysphagia as recommended
 by a trained speech therapist;

 -  clinical diagnosis of cerebrovascular diseases, confirmed by CT head scan. The reason
 for restricting the subjects to those with cerebrovascular disease is that previous
 studies which showed beneficial effects of ACEI on dysphagia were mostly based on
 stroke patients.

 Exclusion Criteria:

 -  life expectancy less than six months;

 -  live outside Shatin area;

 -  systolic blood pressure less than 100 mm Hg;

 -  known intolerance of ACEI;

 -  existing use of ACEI or angiotensin receptor blockers;

 -  symptomatic chronic lung disease or cardiac failure;

 -  frequent withdrawal of enteral tube by patients;

 -  serum creatinine >100 µmol/L;

 -  serum potassium > 5.1 mmol/L.