P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest (NCT03881865) | Clinical Trial Compass
CompletedNot Applicable
P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest
United Kingdom93 participantsStarted 2018-10-08
Plain-language summary
Study Title:
Early recorded P25/30 somatosensory evoked potentials are associated with neurologic prognosis of comatose survivors after out of hospital cardiac arrest.
Design:
Prospective, observational, non-interventional, study - prospective collection of data and interpretation. Analysis of the data and assessment of prognostic value of the P25/30 in critically ill patients post cardiac arrest.
Study Aims:
To be the first attempt to validate the prognostic potential of early recording \[between 24-36 hours post Return Of Spontaneous Circulation\] of P25/30 potentials in comatose survivors who are admitted to a British Intensive care unit after out of hospital cardiac arrest and who are not treated by hypothermic targeted temperature management.
\[Validation of the prognostication significance of P25/30 Somatosensory Evoked Potentials in predicting neurologic outcome in comatose survivors post out of hospital cardiac arrest\].
Outcome Measures:
Primary Endpoint: Neurologic outcome assessed by Cerebral Performance Category score at hospital discharge.
Secondary endpoints: Mortality at hospital discharge and 28 days \[which occurs first\], comparison of prognostic benefit of N20 and P25/30 based multimodal prognostic models.
Population:
Comatose survivors, after out of hospital cardiac arrest, treated in Derriford Hospital ICU, Penrose and Pencarrow wards.
Eligibility:
Adults \[\>18 years old\], out of hospital cardiac arrest, comatose after Return Of Spontaneous Circulation, admission to intensive care Estimated Duration:36 months
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. All adult comatose survivors after out of hospital cardiac arrest who are admitted to Derriford Hospital Intensive Care Unit \[Penrose and Pencarrow wards\]. The cause of cardiac arrest may be cardiac and/or non-cardiac or unknown at the time of enrolment.
. All patients must be comatose before intubation \[GCS equal or lower than 8\].
. All patients must be on one or more invasive organ support \[e.g. Endotracheal intubation and mechanical ventilation, vasopressor and/or inotropic support, Continuous Renal Replacement Therapy Sedated and/or on neuromuscular blocking agents\].
. All patients must be sedated before and during the time of SSEP recording. If clinically indicated, neuromuscular blocking agents may also be used.
. All patients must be on targeted temperature management as per Derriford ICU policy and protocol: For the first 24 hours after ICU admission, the target-temperature is 36°C with temperature control commencing within the first hour after critical care admission. For the next 48 hours the temperature of the patients will be maintained between 36-37°C. The aforementioned temperature targets are achieved with external cooling devices.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.