Controlled MAP in the Brain Injury Patient (COMAT Study)

Study Overview
=================
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)

Official Title
-----------------
Controlled Mean Arterial Pressure of Brain Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial in Critically Ill Patients in the Intensive Care Unit

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Device: EV1000 and closed-loop system
* Device: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: manual versus automated management of MAP
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EV1000 monitor<br>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 | Device: Control group<br>* This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)<br>|
| Experimental: EV1000 monitor + closed-loop system<br>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 | Device: EV1000 and closed-loop system<br>* This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure (MAP) | percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP) | 48 hours post-admission in the intensive care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of case time spent in Hypotension | percentage time spent with MAP below 5 mmHg of the predefined MAP | 48 hours post-admission in the intensive care unit | 
| Percentage of case time spent Hypertension | percentage time spent with MAP above 5 mmHg of the predefined MAP | 48 hours post-admission in the intensive care unit | 
| Cerebral perfusion pressure | Measure of Cerebral perfusion pressure during the treatment time (evolution of Cerebral perfusion pressure over time) | 48 hours post-admission in the intensive care unit | 
| Intracranial pressure | Measure of intracranial pressure during the treatment time (evolution over time) | 48 hours post-admission in the intensive care unit | 
| Intracranial pressure Hypertension | percentage of intracranial pressure over 20 mmHg during the treatment period | 48 hours post-admission in the intensive care unit | 
| Fluid received | comparison of amount of fluid received during the treatment period | 48 hours post-admission in the intensive care unit | 
| Amount of vasopressor | amount of vasopressor received during the treatment period | 48 hours post-admission in the intensive care unit | 
| Length of stay in the intensive care unit | comparison of the length of stay in the intensive care unit between both groups. | 30 days post-admission in the intensive care unit | 
| mean arterial pressure (MAP) | MAP over the treatment period | 48 hours post-admission in the intensive care unit | 
| stroke volume | stroke volume over the treatment period | 48 hours post-admission in the intensive care unit | 
| cardiac index | 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 | 48 hours post-admission in the intensive care unit | 
| Transcranial doppler | measure of mean cerebral velocity of mean cerebral artery | 48 hours post-admission in the intensive care unit |