A Prospective Parallel Group Feasibility Study of the Use of Electroencephalogram-Based Sedation Depth Monitoring in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation.
Extracorporeal Membrane Oxygenation (ECMO) provides cardiorespiratory support for patients with cardiac or respiratory failure, who often require heavy sedation. Managing sedation during ECMO is challenging due to its effect on sedatives. Sedation scores lack sensitivity for deep sedation. EEG-based sedation monitoring, such as Bispectral Index (BIS) monitoring, may reduce sedative drug requirements and benefit patient outcomes. However, the value of this monitor in ECMO care has yet to be published. The lack of feasibility and clinical studies evaluating BIS in ECMO care prompted the planned research.
The study investigates the feasibility of the BIS monitoring method for Venovenous (VV)-ECMO patients. A prospective parallel-group feasibility study will be conducted. For 48 hours, fifteen patients will be observed as having BIS monitoring adjunct to a standard sedation score, and another fifteen will not have BIS monitoring. Sedative requirements will be assessed in the groups to identify differences consistent with drug titration, proving the feasibility of the study. Safety and events records will explore potential unwanted side effects during BIS monitoring. The recruitment and drop-out rates will be estimated. Staff satisfaction surveys will explore modifiable factors for a future clinical study. Staff contribution is essential because BIS monitoring must be feasible for any ICU staff in any hospital to perform reliably, and studies must be designed around robust intervention and data collection methods. Correlations between the BIS values and the standard sedation score will be investigated. A positive correlation would confirm the usefulness and sensitivity of BIS monitoring in ECMO sedation; a negative or no correlation would require alternative explanations or a different study design.
This study will be the first to investigate the role of BIS monitoring as an adjunct to a standard sedation score in ECMO care. This original approach will scientifically explore BIS monitoring feasibility in the ECMO population. Unlike previous pharmacokinetic studies, this study will approach ECMO sedation from a pharmacodynamic perspective. The study will provide data to inform the design of a large-scale clinical study with the appropriate sample size calculations to explore the direct clinical benefit of BIS monitoring during ECMO treatments. If BIS monitoring is deemed feasible for ECMO, clinicians will have an evidence base to use it for this patient population.
Study start date: January 2022.
Study end date: January 2026, part time doctoral fellowship.
Funder: Medtronic limited
Team
Prof. Bhuvaneswari Krishnamoorthy (Bibleraaj)
Dr. Sam Howitt
Dr. Lajos Szentogyori