Severe traumatic brain injury requiring sedation to control intracranial pressure Injury, Occupational Diseases, Poisoning
Conditions
Interventions
The investigational medical device of this study, which is called MONTE, provides novel monitoring information to the clinicians in charge of the management of patients with severe Traumatic Brain Inj
Sponsors
Universitair Ziekenhuis Leuven
Eligibility
Sex/Gender
All
Age
18 Years to 105 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (age =18 years old) 2. Severe traumatic brain injury 3. Continuous invasive intraparenchymal ICP monitoring 4. Patient requires sedation
Exclusion criteria
Exclusion criteria: 1. Do-not-resuscitate (DNR) order 2. Bilateral dilated pupils or absence of pupil reflection 3. Pregnancy 4. Known pre-existing neurocognitive disorders or brain dysfunctions 5. Known pre-existing spinal cord injuries with loss of motor function 6. Primary decompressive craniectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The feasibility of the proposed methodology, quantified with the following measures: 1.1. The adherence to the number of clinical evaluations is equal to or higher than 75% 1.2. The adherence to the number of clinical evaluations is equal to or higher than 75% Clinical evaluations will last up until 1 week after the patient’s study inclusion OR will be interrupted earlier in case invasive ICP monitoring is interrupted for more than 24 hours OR in case the patient undergoes decompressive craniectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of performed clinical evaluations without technical problems is equal to or higher than 90%. Clinical evaluations will last up until 1 week after the patient’s study inclusion OR will be interrupted earlier in case invasive ICP monitoring is interrupted for more than 24 hours OR in case the patient undergoes decompressive craniectomy. 2. Estimated costs and time required for an interventional study that is powered for safety and clinical benefits (effectiveness). Based on the pilot study, a future larger-scale clinical investigation can be planned, which will be properly powered for effectiveness and safety endpoints. Proper power calculation will give us an estimation of costs for the future study (based on the amount of patients). The time needed for the future study, based on the power calculation, is defined as the start of study patient recruitment until 6 months follow-up of the last patient (last patient last visit). 3. Validity of the randomization procedure, evaluated by verifying that at the end of the study period the same number of patients were recruited in both randomization groups. 4. Estimated recruitment rates, drop-out rate and incidence of ICU mortality 5. Insights on the true effect of the intervention: 5.1. Percentage of time with harmful ICP doses 5.2. Number of events of harmful ICP doses 5.3. Number of events of extremely elevated ICP (defined as ICP >28 mmHg for more than 10 minutes) 5.4. Percentage of time with impaired cerebrovascular autoregulation (defined as low-frequency autoregulatory index or Lax >0) 5.5. Duration of sedation 5.6. Percentage of patients that underwent Tier 3 therapies (decompressive craniectomy, hypothermia or metabolic suppression) These clinical evaluations will last up to 1 week after the patient’s study inclusion 5.7. Long-term neurological outcomes are measured by GOSE questionnaire collected at 6 months from the day of patient inclusion 6. Understanding of the study questionnaires measured by the | — |
Countries
Belgium, Italy, Netherlands
Contacts
Public ContactLiese Mebis
Outcome results
None listed