COntrolled MAp Trauma Brain Injury (COMAT Study)

Study Overview
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Brief Summary
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The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

Detailed Description
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In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. 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 vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management. All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP. The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.

Official Title
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Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial

Conditions
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Closed-Loop Communication

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated Exclusion Criteria: Glasgow score >8 Bilateral mydriasis at the initial management

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: EV1000 and closed-loop system<br>* This system will recommend when patients need fluid or not and adjust vasopressor administration automatically<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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEAN ARTERIAL PRESSURE (MAP) | time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study. | 48 hours post-admission in the intensive care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension incidence | percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission | 48 hours post-admission in the intensive care | 
| Hypertension incidence | percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission | 48 hours post-admission in the intensive care | 
| Pulsatility index | measure of pulsatility index using the Transcranial doppler ultrasound | baseline (admission to the intensive care unit) | 
| Pulsatility index | measure of pulsatility index using the Transcranial doppler ultrasound | 24 hours post-admission to the intensive care unit | 
| Pulsatility index | measure of pulsatility index using the Transcranial doppler ultrasound | 48 hours post-admission to the intensive care unit | 
| Mean velocity | measure of mean velocity using the Transcranial doppler ultrasound | baseline (admission to the intensive care unit) | 
| Mean velocity | measure of mean velocity using the Transcranial doppler ultrasound | 24 hours post-admission to the intensive care unit | 
| Mean velocity | measure of mean velocity using the Transcranial doppler ultrasound | 48 hours post-admission to the intensive care unit | 
| diastolic velocity | measure of diastolic velocity using the Transcranial doppler ultrasound | baseline (admission to the intensive care unit) | 
| Diastolic velocity | measure of diastolic velocity using the Transcranial doppler ultrasound | 24 hours post-admission to the intensive care unit | 
| Diastolic velocity | measure of diastolic velocity using the Transcranial doppler ultrasound | 48 hours post-admission to the intensive care unit | 
| Fluid received | comparison of amount of fluid received during the first 48 hours post admission | 48 hours post-admission in the intensive care | 
| Amount of vasopressor | amount of vasopressor received during the first 48 hours post admission | 48 hours post-admission in the intensive care | 
| 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 | 
| Mean arterial pressure (MAP) | MAP over the first 48 hours postadmission in the intensive care | 48 hours post-admission in the intensive care | 
| Stroke volume | stroke volume over the first 48 hours postadmission in the intensive care | 48 hours post-admission in the intensive care | 
| cardiac index | cardiac index over the first 48 hours postadmission in the intensive care | 48 hours post-admission in the intensive care |