intracranial hypertension after severe traumatic brain injury
Conditions
Interventions
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (age 18 years or older) Severe traumatic brain injuryContinuous invasive intraparenchymal intracranial pressure monitoringPatient requires sedation
Exclusion criteria
Exclusion criteria: Do-not-resuscitate (DNR) orderBilateral dilated pupils or absence of pupil reflection PregnancyKnown pre-existing neurocognitive disorders or brain dysfunctionsKnown pre-existing spinal-cord injuries with loss of motor-functionPrimary decompressive craniectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the assessment of the feasibility of the proposed methodology. Feasibility aims at assessing the following:Evaluating study feasibility and deciding upon research methods.Evaluating the feasibility of the technical set-up of the study.Estimating the time and costs required for the project.Evaluating the randomization procedure.Feasibility will be quantified with the following measures:Main feasibility endpoint: Adherence to the CIPThe adherence to the number of clinical evaluations is equal or higher than 75%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary feasibility endpoints: Adherence to the CIP and technical feasibilityThe number of performed clinical evaluations without technical problems is equal or higher than 90%.Estimate of the costs and time required for an interventional study that is powered for safety and clinical benefits (effectiveness). Evaluate the validity of the randomizationprocedure.Estimate of the recruitment rates, drop-out rate and incidence of ICU-mortality. Insights on the true effect of the intervention.Assessing the understanding of the study questionnaires.In view of a future interventional study, during the pilot study potential future endpoints for safety and clinical benefits (effectiveness) will be collected and analysed. We report below the list of additional collected endpoints, “s" indicates an endpoint that will evaluate safety, while “e" indicates an endpoint that will evaluate effectiveness.ICU-mortality (“s",”e")number of events of harmful ICPdoses (“e")percentage of time with harmful ICP doses (“e”)number of events of extremelyelevated ICP (defined as ICP>28mmHg for more than 10 minutes) (“e") percentage of time with impaired cerebrovascular autoregulation ("e")duration of sedation (“e”)percentage of patients that underwent Tier 3 therapies (decompressive craniectomy, hypotherm | — |
Countries
Belgium, Italy, Netherlands
Contacts
Public ContactCWE Hoedemaekers
Radboud Universitair Medisch Centrum
Outcome results
None listed