About this trial
The risk associated with arterial hypotension during anesthesia for intensive care sedation has been demonstrated, but the threshold at which consequences for perfusion of one or more organs appear varies according to the mechanism of hypotension, associated abnormalities (HR, cardiac output and oxygen transport) and the patient's terrain.
Currently, a mean arterial pressure greater than 60 mm Hg (1) and a reduction of less than 30-50% from the value measured before sedation are commonly used to ensure good perfusion of all organs. In intensive care, it is recommended to maintain a MAP between 60 and 70 mmHg and a Cerebral Perfusion Pressure (CPP) \> 50 mmHg for neurocompromised patients with Intra Cranial pressure (ICP) measure. Normally, cerebral blood flow is self-regulated, allowing adaptation of cerebral blood flow to oxygen requirements at different levels of high and low blood pressure. However, this protective mechanism may fail for a degree of hypotension that depends on several factors such as the age or vascular status of the patient.
The aim of the study is to measure non-invasively, easily and reliably the variations of cerebral perfusion in patients with or without cardiovascular risk factors during controlled variations performed during routine care to set the blood pressure level within the recommended safety standards during sedation in intensive care unit.
What is the tolerable target BP level for a patient under continuous sedation in the ICU? Is there a simple and non-invasive way to measure the level of cerebral blood flow autoregulation and especially the adequacy of the brain's oxygen requirements?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (> 18 years old)
Requiring an intensive care unit admission
Informed patient who has expressed his/her non-opposition to participating in this research or, if applicable, trusted person/relative of patient unable to express his/her wishes
Disqualifiers
Patients under 18 years of age.
Patient, or if applicable, trusted person / close relative / parent of patient unable to express his/her will, opposed to participation in the protocol
Pregnant woman
Patient under judicial protection
Trial population
ICU patient under sedation
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-invasive Measurement of cerebral blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) (Mean velocity, Vm, cm/s)
Diagnostic testMeasurement of cerebral blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) (Mean velocity, Vm, cm/s) (recorded on Data Warehouse Connect). For all patients Vm in (cm/s) will be collected during the adjustment of the mean arterial pressure level between 90% and 70% of the baseline value, without ever going below 60 mmHg for the patients at low risk and 80 mmHg for the patients at high cardiovascular risk. For neuro-injured patients with intracranial pressure monitoring (ICP), the lower limit of cerebral perfusion pressure (CPP = MAP - ICP) will be set at 50 mmHg
Treatment groups
Trial outcomes
Primary outcomes
Mean arterial pressure
Continuous non-invasive measurement of mean arterial pressure (MAP, mmHg)
Cerebral blood velocity in the middle cerebral artery
Measurement of cerebral blood velocity in the middle cerebral artery by transcranial pulsed Doppler (TCD) (Mean velocity, Vm, cm/s)
Burst suppression
Continuous measurement of burst suppression (BS) (%)
95% spectral frequency front
Continuous measurement of spectral frequency front (SEF95) on the frontal EEG
Secondary outcomes
Cerebral O2 saturation
Continuous measurement of cerebral O2 saturation (%) by near infraRed spectroscopy
Sponsors and contacts
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
INSERM UMR-942, Paris, France
Collaborator
LMS Polytechnique and M3DISIM, Inria
Collaborator