Cerebral Perfusion Variation During Blood Pressure Changes in ICU

NCT05804773 | Recruiting

• 2 other identifiers: APHP2300732023-A00059-36
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Intensive Care Unit Syndrome

Keywords

Cerebrovascular Autoregulation; neurovascular coupling; Individualized vs Standard Blood Pressure Management; Strategies; Multimodal monitoring; Monitoring Brain Oxygen Saturation

Outcome Measures

Primary Outcomes (5)

• Mean arterial pressure

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

  1 day

• 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)

  1 day

• Burst suppression

  Continuous measurement of burst suppression (BS) (%)

  1 day

• 95% spectral frequency front

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

  1 day

• delivered doses of hypnotics, morphine and paralytic agents

  Quantification of delivered doses of hypnotics, morphine and paralytic agents

  1 day

Secondary Outcomes (1)

• Cerebral O2 saturation

  1 day

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patient under sedation

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient not affiliated to a social health system

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-942, Paris, France: collaborator
• LMS Polytechnique and M3DISIM, Inria: collaborator

Study Sites (1)

Hôpital Lariboisière

Paris, France, 75010, France

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Doppler, Transcranial

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Joaquim MATEO, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

• Fabrice VALLEE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

149958374; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD, PhD

CONTACT

149958071; vallee.fabrice@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: July 9, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)