Pneumonia Clinical Trial
Official title:
A Randomized Placebo Controlled Trial of Low Dose Angiotensin Converting Enzyme Inhibitor to Prevent Pneumonia in Older People Who Require Tube Feeding Because of Neurological Dysphagia
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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