COntrolled MAp Trauma Brain Injury (COMAT Study)
- Conditions
- Closed-Loop Communication
- Interventions
- Device: EV1000 and closed-loop system
- Registration Number
- NCT03792581
- Lead Sponsor
- Erasme University Hospital
- 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 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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated
- Glasgow score >8
- Bilateral mydriasis at the initial management
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EV1000 monitor EV1000 and closed-loop system 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 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.
- Secondary Outcome Measures
Name Time Method Length of stay in the Intensive care unit 30 days post-admission in the intensive care 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 MAP over the first 48 hours postadmission in the intensive care
Stroke volume 48 hours post-admission in the intensive care stroke volume over the first 48 hours postadmission in the intensive care
cardiac index 48 hours post-admission in the intensive care cardiac index over the first 48 hours postadmission in the intensive care
Hypotension incidence 48 hours post-admission in the intensive care percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Hypertension incidence 48 hours post-admission in the intensive care percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Pulsatility index 48 hours post-admission to the intensive care unit measure of pulsatility index using the Transcranial doppler ultrasound
Mean velocity 48 hours post-admission to the intensive care unit measure of mean velocity using the Transcranial doppler ultrasound
diastolic velocity baseline (admission to the intensive care unit) measure of diastolic velocity using the Transcranial doppler ultrasound
Diastolic velocity 48 hours post-admission to the intensive care unit measure of diastolic velocity using the Transcranial doppler ultrasound
Fluid received 48 hours post-admission in the intensive care comparison of amount of fluid received during the first 48 hours post admission
Amount of vasopressor 48 hours post-admission in the intensive care amount of vasopressor received during the first 48 hours post admission
Trial Locations
- Locations (1)
Joosten Alexandre
🇫🇷Paris, LE Kremlin Bicetre, France