Closed-Loop Communication
Conditions
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.
Interventions
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
Sponsors
Bicetre Hospital
University of California, Irvine
University of California, Los Angeles
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Manual versus automated management of MAP
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated
Exclusion criteria
* Glasgow score \>8 * Bilateral mydriasis at the initial management
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline (admission to the intensive care unit) | measure of pulsatility index using the Transcranial doppler ultrasound |
| Mean velocity | baseline (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 | 24 hours post-admission to the intensive care unit | measure of diastolic velocity using the Transcranial doppler ultrasound |
| 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 |
| Amount of vasopressor | 48 hours post-admission in the intensive care | amount of vasopressor received during the first 48 hours post admission |
| 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 |
| Fluid received | 48 hours post-admission in the intensive care | comparison of amount of fluid received during the first 48 hours post admission |
Countries
France
Outcome results
None listed