What is the study about?

The PhEAST study aims to help stroke patients who are unable to swallow food and drink to re-train their brain so that they can swallow independently again.

Acute stroke (ischaemic, haemorrhagic) is common and complicated by oropharyngeal dysphagia in at least 50% of patients, many of whom remain dysphagic at one year. Dysphagia often requires enteral feeding and is complicated by aspiration/pneumonia, malnutrition, prolonged hospital stay, institutional care after hospital and death. Hence, it adds considerably to the physical, emotional and financial costs of stroke, delays discharge from hospital, and adds to health service usage and institutional burden. 

What is being tested in the study?

The purpose of the trial is to assess whether Pharyngeal Electrical Stimulation PES is safe and effective at improving post-stroke dysphagia.

The trial is an international prospective randomised open-label blinded-endpoint (PROBE) parallel group superiority phase IV effectiveness trial and the setting is secondary care, acute stroke services. The health economic analysis will be conducted from a health and social services perspective but because of the nature of this intervention and the target age group will include the broad perspective on the individual and their families. The incremental cost for pharyngeal electrical stimulation (PES) versus usual care will be calculated. Key collection points for health economic data are day 14: EQ5D-5l by patient or proxy. Discharge: EQ5D-5l

(VAS and form), Health Care Resource use. Day 90: EQ5D-5l (VAS and form),

What are we trying to find out?

Primary

• Does 6 days of PES accelerate return to oral intake of food and drink as assessed using the dysphagia severity rating scale and blinded to treatment?

Secondary

• Does PES improve swallowing and reduce pneumonia, antibiotic exposure, hospital length of stay and disability?
• Does PES increase quality-of-life?
• Is PES cost effective as compared to usual care?
• What subgroups predict response to PES?

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)

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