Emergency VV-ECMO admissions Not Applicable
Conditions
Interventions
Thirty consecutive VV-ECMO patients will be included in the study. Due to the observational study design, the researcher will alternate the BIS monitor allocation instead of randomisation. Hence, 15 p
only the RASS score will guide the sedation.
Sedation management using the RASS score only:
According to the standard departmental practice, all 30 patients’ RASS scores will be determined hourly by
simultaneously with other monitors and electrodes (ECG, blood pressure, saturation probes, and other ECMO-related monitors). The BIS electrodes will be changed to a new electrode every 24 hours as per
Sponsors
University of Salford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any ethnic background 2. Already sedated or continuous intravenous sedation will be commenced shortly before or parallel with VV-ECMO initiation 3. VV-ECMO treatment
Exclusion criteria
Exclusion criteria: 1. Patients who are younger than 18 years old 2. Patients who are not sedated with intravenous agents during the planned study period 3. Patients with a significant skin lesion or damaged area on the forehead make the BIS electrode placement impossible or risky concerning further skin damage 4. Known allergy to the BIS electrode materials 5. Patients who are sedated with ketamine during the study period. Ketamine may artificially increase BIS number despite an adequate level of sedation. Newer technologies address these issues, but including this patient group is not practical; it would require advanced knowledge in BIS monitoring beyond the daily clinical routine. 6. Those cases will be excluded with a strong suspicion of significant neurological damage diagnosed with a CT scan (This scenario would be an exclusion criterion for ECMO; however, these patients might still have ECMO due to diagnostic difficulties and ambiguities; therefore, they will be monitored during the study period). Unless the ECMO is withdrawn early, these patients will be considered subgroup analysis subjects. The analysis will investigate whether the BIS monitoring would show an early sign of neurological injury. These unfortunate cases will not be included in the planned completed 15 monitored patients. These cases may impact the sample size calculation for a future clinical study. 7. If active treatment is withdrawn earlier than the study period 8. VA-ECMO (the sedation management priorities can differ in VA-ECMO cases because these patients’ sedation is often short and frequently awake during their VA-ECMO course)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedative drug titration according to the BIS values will demonstrate the feasibility of BIS monitoring. To demonstrate sedative drug titration, sedative drug requirements (propofol, opioids, clonidine/dexmedetomidine, midazolam, and neuromuscular blocking agent doses measured in the appropriate equivalents and milligrams) will be recorded using BIS-guided sedation (BIS number is recorded in dimensionless numbers) and only RASS score-guided sedation (recorded in numbers) during the first 48-hour VV-ECMO care. If drug titration occurs, these doses will differ between the two groups, confirming that the nursing staff can use the BIS monitor appropriately. So, they can reliably titrate the drugs according to the departmental sedation protocol to achieve the intended RASS score and BIS values. Hence, the method is feasible for nurse-led sedation, and a larger clinical study is doable. The data will be downloaded or manually transcribed into the eCRF. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and other events (ECMO flow issues, inadvertent device removal, skin irritation, cardiac arrest, mortality during the first 48 hours, ICU mortality, etc) recorded in the eCRF after the 48-hour data collection period for the monitored and control groups to explore potential unwanted side effects during BIS monitoring 2. Monitored clinical parameters and sedative drug requirements (propofol, opioids, benzodiazepines, clonidine doses in the appropriate equivalents) in the BIS monitored and the control group in the 48-hour data collection period. The proportion of lost data and the causes will be analysed. Although the parameters will be recorded automatically in the electronic patient record (monitoring system), unforeseen technical complications may cause data loss. Certain limitations can be revealed in the case of an incomplete database. On the other hand, the recorded amount of drug doses may allow for calculating reduced drug use; beneficial cost implications could be revealed. 3. The estimated potential recruitment and drop-out rate. Due to the relative uncertainty of the VV-ECMO admission rate (ECMO is an emergency rescue service) and the suitability of these patients (variable survival and neurological morbidity rates), the recruitment and drop-out assessments are crucial for estimating a future prospective clinical study sample size. In addition, the participants or their legal representatives will be asked about their views and willingness to participate in a potentially randomised study. Low acceptance of randomisation might influence the design of a future clinical study. 4. The feedback of medical and nursing staff within 1 week after they finished their shifts with the monitored patients, exploring their satisfaction with BIS monitoring. Staff contribution is essential for any prospective studies because BIS monitoring must be feasible for any ICU staff in any hospital to perform reliably. Therefore, future research must be designed around robus | — |
Countries
England, United Kingdom
Outcome results
None listed