Brain Injuries
Conditions
Brief summary
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)
Detailed description
In brain injury patients, the maintenance of MAP within a very narrow range is desired to avoid complications related to hypoperfusion (undertreatment) or hypertension (over treatment). However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust drugs infusions. Using a novel automated system can overcome this issue and may lead to more time in MAP target (+/- 5mmHg) than the traditional management. After initial rescuscitation of the patients, patients in both groups will have the same baseline maintenance fluid administration of 1-2 ml/kg/h of crystalloid solution and additionnal fluid boluses administered following the EV1000 monitoring device. The only difference will be the management of vasopressor titration (manual by nurses vs automated via a closed-loop system)
Interventions
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
DEVICEControl group
This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
Sponsors
University of California, Los Angeles
University of California, Irvine
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
manual versus automated management of MAP
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* severe brain injury patients (Glasgow score \<9), intubated, ventilated and sedated.
Exclusion criteria
* Glasgow score \> 8 * Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean arterial pressure (MAP) | 48 hours post-admission in the intensive care unit | percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of case time spent in Hypotension | 48 hours post-admission in the intensive care unit | percentage time spent with MAP below 5 mmHg of the predefined MAP |
| Percentage of case time spent Hypertension | 48 hours post-admission in the intensive care unit | percentage time spent with MAP above 5 mmHg of the predefined MAP |
| Cerebral perfusion pressure | 48 hours post-admission in the intensive care unit | Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time) |
| Intracranial pressure | 48 hours post-admission in the intensive care unit | Measure of intracranial pressure during the treatment time (evolution over time) |
| Intracranial pressure Hypertension | 48 hours post-admission in the intensive care unit | percentage of intracranial pressure over 20 mmHg during the treatment period |
| stroke volume | 48 hours post-admission in the intensive care unit | stroke volume over the treatment period |
| Amount of vasopressor | 48 hours post-admission in the intensive care unit | amount of vasopressor received during the treatment period |
| Length of stay in the intensive care unit | 30 days post-admission in the intensive care unit | comparison of the length of stay in the intensive care unit between both groups. |
| mean arterial pressure (MAP) | 48 hours post-admission in the intensive care unit | MAP over the treatment period |
| cardiac index | 48 hours post-admission in the intensive care unit | cardiac index over the treatment period. This will be the mean values over the procedure. Measurements recorded each 20 seconds and averaged for the procedure. The unit is l/min/m-2 |
| Transcranial doppler | 48 hours post-admission in the intensive care unit | measure of mean cerebral velocity of mean cerebral artery |
| Fluid received | 48 hours post-admission in the intensive care unit | comparison of amount of fluid received during the treatment period |
Countries
France
Outcome results
None listed