Controlled MAP in the Brain Injury Patient (COMAT Study)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Brain Injuries

Treatments: Device: EV1000 and closed-loop system; Device: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03991052

APHP180501

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 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)

Full 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)

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 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: Control group

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