Dysphagia intervention for intubated cardiac surgery patients in ICU
Research type
Research Study
Full title
A single centre, open label, blinded outcome assessment, randomised, feasibility study testing a sensory-motor swallowing treatment during intubation in cardiac surgery intensive care.
IRAS ID
275944
Contact name
Danny McAuley
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
Swallowing difficulties or dysphagia in critical care are common and happen when a patient's swallowing muscles become weakened, often resulting in food / fluids entering the airway (known as aspiration). The risk of developing dysphagia and aspiration increases the longer breathing tubes are in a patient's upper airway (i.e. intubated and ventilated), leading to pneumonia, longer lengths of intensive care (ICU) and hospital stays and even death in critically ill patients.
Three recent studies tested the effectiveness of electrical stimulation to treat dysphagia in respiratory and stroke ICU patients. While results are awaited from the respiratory study, the two stroke studies found mixed results. To date, no studies have tested this treatment with cardiac surgery ICU patients
This feasibility study aims to establish if providing electrical stimulation to ventilated patients in ICU, is safe, well tolerated and reduces or prevents dysphagia and aspiration. We will recruit 50 patients and will randomly assign 25 to the sensory-motor swallowing intervention (hereafter known as electrical stimulation group) and 25 will receive no stimulation. Patients in the electrical stimulation group will receive 60 minutes of daily sensory electrical stimulation and simultaneous tongue resistance exercises (when alert enough to complete exercises) while ventilated. Once breathing tubes are removed, we will assess swallow function via endoscopy on two separate occasions (2 days after treatment ends (which is normal clinical practice in intensive care) and 6 weeks following hospital discharge (an additional assessment)). Patients in both groups who continue to present with swallowing difficulties will receive standard NHS dysphagia care (only delivered after extubation) from the direct care team.The study will take place in Belfast Health and Social Care Trust. All cardiac surgery patients who are still intubated 4 days after their surgery are eligible to participate. This feasibility study may have potential to lead to a larger trial.
REC name
HSC REC A
REC reference
20/NI/0042
Date of REC Opinion
29 May 2020
REC opinion
Further Information Favourable Opinion