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 range18 Years
SexALL
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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.