Cerebral Perfusion Variation During Blood Pressure Changes in ICU

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

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 test

    Measurement 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Mean arterial pressure

Continuous non-invasive measurement of mean arterial pressure (MAP, mmHg)

Time frame
1 day
2

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)

Time frame
1 day
3

Burst suppression

Continuous measurement of burst suppression (BS) (%)

Time frame
1 day
4

95% spectral frequency front

Continuous measurement of spectral frequency front (SEF95) on the frontal EEG

Time frame
1 day

Secondary outcomes

1

Cerebral O2 saturation

Continuous measurement of cerebral O2 saturation (%) by near infraRed spectroscopy

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

INSERM UMR-942, Paris, France

Collaborator

LMS Polytechnique and M3DISIM, Inria

Collaborator