PRO-BIS on ECMO feasibility study
Research type
Research Study
Full title
A prospective parallel group feasibility study of the use of electroencephalogram based sedation depth monitoring in adults receiving venovenous extracorporeal membrane oxygenation
IRAS ID
305985
Contact name
Lajos Szentgyorgyi
Contact email
Sponsor organisation
University of Salford
ISRCTN Number
ISRCTN79335747
Clinicaltrials.gov Identifier
University of Salford Ethics, HSR2223-001
Duration of Study in the UK
1 years, 4 months, 25 days
Research summary
Extracorporeal Membrane Oxygenation (ECMO) supports patients in heart and lung failure with the blood getting oxygenated outside of their body in a unique device. These patients are put to sleep. This artificial sleep (sedation) is challenging for both the patients and staff. Critical care staff use sedation scores, which are subjective and not good enough in a deep sleep. The bispectral index (BIS) monitor senses brain electrical waves that show if somebody is asleep. This monitor is routinely used in the operating theatres during general anaesthetic; however, the value of this monitor in ECMO care has not been investigated. Its use is simple, and BIS-guided sedation may reduce drug requirements, which might have potential benefits.
The proposed study will look at whether BIS monitoring is possible during venovenous (VV)-ECMO to reduce the drug requirement. For 48 hours, fifteen individuals will be observed as having BIS monitoring with standard sedation score, and another fifteen control patients will not have BIS monitoring. Sedative drug requirements will be assessed in the groups to identify differences, proving the feasibility of the study. Researchers will explore potential unwanted side effects during BIS monitoring. The recruitment will be estimated for a future large-scale clinical study. A positive correlation between the BIS and sedation scores would confirm the usefulness and sensitivity of BIS monitoring in ECMO sedation. However, alternative explanations or a different study are needed if there is no correlation.
To date, this study will be the first to investigate the role of BIS monitoring in ECMO care. Unlike previous studies, this study will measure ECMO sedation in numbers to help manage optimal therapy. The study will provide data for a large-scale clinical study. If BIS monitoring is deemed doable for ECMO, clinicians will have evidence to use it in ECMO.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0316
Date of REC Opinion
17 Nov 2022
REC opinion
Further Information Favourable Opinion