COntrolled MAp Trauma Brain Injury (COMAT Study)

Free University of Brussels (ULB)

Status: Withdrawn

Conditions: Closed-Loop Communication

Treatments: Device: EV1000 and closed-loop system

Study type: Interventional

Funder types: Other

Identifiers

NCT03792581

2018-A02976-49

Details and patient eligibility

About

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)

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated

Exclusion criteria

• Glasgow score >8
• Bilateral mydriasis at the initial management

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

EV1000 monitor

Active Comparator group

Description:

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

Treatment:

Device: EV1000 and closed-loop system

EV1000 monitor + closed-loop system

Experimental group

Description:

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

Treatment:

Device: EV1000 and closed-loop system