Controlled MAP in the Brain Injury Patient (COMAT Study)
- Conditions
- Brain Injuries
- Interventions
- Device: Control groupDevice: EV1000 and closed-loop system
- Registration Number
- NCT03991052
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- severe brain injury patients (Glasgow score <9), intubated, ventilated and sedated.
- Glasgow score > 8
- Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EV1000 monitor Control group MAP management will be done as usual (adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system EV1000 monitor + closed-loop system EV1000 and closed-loop system Fluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Transcranial doppler 48 hours post-admission in the intensive care unit measure of mean cerebral velocity of mean cerebral artery
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
stroke volume 48 hours post-admission in the intensive care unit stroke volume 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
Fluid received 48 hours post-admission in the intensive care unit comparison of amount of fluid received during the treatment period
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 Hypertension 48 hours post-admission in the intensive care unit percentage of intracranial pressure over 20 mmHg during the treatment period
Intracranial pressure 48 hours post-admission in the intensive care unit Measure of intracranial pressure during the treatment time (evolution over time)
mean arterial pressure (MAP) 48 hours post-admission in the intensive care unit MAP 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.
Trial Locations
- Locations (1)
Bicêtre hospital
🇫🇷Le Kremlin-Bicêtre, France