Macro- and Microcirculation Crosstalk in Brain-damaged Patients Under Anesthesia or in Intensive Care

NCT05285514 | Unknown

• 2 other identifiers: APHP2113172021-A02375-36
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with severe brain injury, maintenance and control of blood pressure is at the very first point in the management strategy, whether in anesthesia or in intensive care. In order to restore cerebral perfusion pressure (CPP) to appropriate levels (60-70 mmHg) while ensuring optimal perfusion of other vital organs, intravenous administration of vasodilator, inodilator or vasoconstrictor vasoactive agents is commonly used. These vasoactive agents, widely used to correct hypotension or hypertension, have their own effects on the load conditions of the left ventricle and the tone of the arterial tree, but also have effects on the microcirculation. The microcirculatory status of a tissue cannot be reliably predicted by considering only the macrocirculatory parameters usually measured. Therefore, in situations where organ perfusion is inadequate or compromised, patient management that includes the integration of the impact of vasoactive agents on the microcirculation seems essential for comprehensive hemodynamic treatment. The non-invasive study of microcirculatory perfusion and its interactions with the macrocirculatory network, using a minimally invasive method such as videomicroscopy, should allow a better use of the treatments used. For cerebral patients, routine management already includes very complete monitoring of all cardiopulmonary and cerebral systemic parameters. It is therefore imperative to study and propose new minimally invasive modalities for monitoring the microcirculation in order to define new therapeutic targets that take into account the microcirculatory compartment.

Conditions

Brain Injury

Keywords

Hemodynamic monitoring; Microcirculation; Macro-microcirculation crosstalk; Vasoactive agents

Outcome Measures

Primary Outcomes (2)

• Capillary density

  For all patients, Capillary density by sublingual video microscopy (proportion of perfused vessels; PPVSL / percentage and the heterogeneity index; HETSL / H-unit) will be collected in separate time periods: 1. Baseline before administration of the vasoactive agent 2. After 5 minutes 3. After stabilization 15 minutes

  Duration of the surgical intervention (1 day)

• Microcirculatory flow

  For all patients, Capillary flow estimation using sublingual videomicroscopy (Microcirculatory Flow Index MFISL/ unit FI) will be collected in separate time periods: 1. Baseline before administration of the vasoactive agent 2. After 5 minutes 3. After stabilization 15 minutes

  Duration of the surgical intervention (1 day)

Study Arms (1)

Brain-damaged patients under anesthesia and requiring the administration of a vasoactive agent

Patients with severe brain injuries over 18 years of age are eligible to participate in this protocol: head trauma, subarachnoid hemorrhage, ischemic or hemorrhagic stroke and requiring the administration of a vasoactive agent as part of routine medical care to restore Cerebral Perfusion pressure (CPP).

Diagnostic Test: Comparison of macro- and microcirculatory parameters

Interventions

Comparison of macro- and microcirculatory parameters DIAGNOSTIC_TEST

Microcirculation examination using sublingual videomicroscopy, tissue O2 saturation (StO2) by NIRS and transcutaneous CO2 pressure (tcpCO2) monitoring, in conjunction with macrocirculatory parameters measures including cardiac output, arterial pressure and pulsed O2 saturation, in order to establish the relationship between the macrocirculatory changes in blood pressure and cardiac output and the microcirculatory flow and capillary density during vasoactive agent use." . Participants receive interventions as part of routine medical care to restore Cerebral Perfusion pressure (CPP) to appropriate levels (60-70 mmHg)

Brain-damaged patients under anesthesia and requiring the administration of a vasoactive agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years old) with brain damage, undergoing general anesthesia or intensive care justifying, due to their severity, monitoring of blood pressure and cardiac output.

You may qualify if:

• Adult patients (≥ 18 years old)
• With brain damage
• Benefiting from general anesthesia or resuscitation justifying the placement of an arterial catheter and monitoring of cardiac output
• With hypotension or arterial hypertension requiring intravenous administration of a vasoactive agent to meet the target cerebral perfusion pressure (CPP) of 60-70 mmHg
• Not subject to a measure of legal protection (tutorship/curatorship)
• Patients informed and having expressed their non-objection to participation in this research, or, where applicable, a person of trust / family member / relative of the patient who is unable to express her or his agreement

You may not qualify if:

• Patients under the age of 18
• Pregnant woman
• Patient without affiliation to a social security scheme
• Patient, or, where applicable, person of trust / family member / relative of the patient unable to express her or his agreement, opposed to participation in the study
• Patient subject to a legal protection measure
• Patient benefiting from the State medical assistance (AME) program

Sponsors & Collaborators

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

Study Sites (1)

AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Joaquim MATEO, MD

  AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

  STUDY DIRECTOR

• Fabrice VALLEE, MD, PhD

  AP-HP, Lariboisière Hospital, Department of Anesthesiology and Intensive Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joaquim MATEO, MD

CONTACT

+33 (0)1 49 95 83 74; joaquim.mateo@aphp.fr

Fabrice VALLEE, MD, PhD

CONTACT

+33 (0)1 49 95 80 71; vallee@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 9, 2022
• First Posted: March 17, 2022
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (1)