Guideline-recommended Basic Parameter Adherence in Neurocritical Care Patients (NORMONICU)

University of Giessen

Status: Completed

Conditions: Stroke

Treatments: Diagnostic Test: Time in therapeutic range of vital parameters

Study type: Observational

Funder types: Other

Identifiers

NCT06367543

AZ 117/22

Details and patient eligibility

About

The aim of the planned study project is to assess the current situation regarding the treatment of patients with severe stroke at the neuro-critical care unit. Specifically, determination of whether the target parameters recommended in the guidelines for temperature, systolic blood pressure, mean arterial blood pressure, blood glucose, arterial oxygen partial pressure and arterial carbon dioxide partial pressure had to be maintained. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned.

Full description

Cerebrovascular events include cerebral infarctions as well as intracranial haemorrhages. If the severity of this cerebrovascular damage is so severe, functional damage to the brain occurs, which must be treated regularly in intensive care. In particularly severe cases, patients are analgosedated, intubated and ventilated to treat elevated intracranial pressure (ICP). Especially in these critically ill patients, it is known from numerous studies that adherence to normal physiological parameters of body temperature, blood pressure, serum glucose and ventilation parameters leads to an improvement in the outcome of the patients. This has led to the corresponding guidelines for the treatment of these patients.

In the case of patients with sepsis, it is known that a scientifically proven finding of a better treatment option did not directly lead to an implementation in daily patient care. Only the introduction of treatment and target bundles as a combination of such interventions then led to the implementation of the recommendations and to an improvement in patient care. From this background, the question arises as to whether the above-mentioned measures have been implemented in neurological intensive care medicine for patients with severe cerebrovascular diseases or whether measures such as the introduction and training of target bundles could be useful.

The aim of this research project is to generate new evidence for or against common treatment algorithms in fields where no randomized data are available. Among other things, it will be analysed to what extent early management on intensive care units affect outcomerelevant parameters. The overall aim is to improve the current level of evidence on the management of patients with severe stroke by analyzing a large database of individualized patient data.

The aim of the planned study project is a national, multicentre retrospective collection of real patient data in specialized neurological/neurosurgical intensive care units of patients with severe cerebrovascular diseases. From these collected data, the reality of treatment is to be presented and guideline adherence is to be calculated. From the planned data analysis, the need for the introduction of cerebrovascular bundles can be derived and planned.

Specifically, a retrospective evaluation of patients who were hospitalized at eight neurocritical care units in eight tertiary centres in Germany. Specifically, it is planned to first identify these patients through a controlling query. Subsequently, various clinical parameters from the routine acute phase will be collected by reviewing the in-house electronic data systems. Aspects of data protection will be observed according to the local institutional guidelines.

Enrollment: 474 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 18
• acute neurovascular disease, i.e. cerebral ischemia, intracerebral hemorrhage or subarachnoid hemorrhage (International Classification of diseases, ICD10, i.e. 160.x, 161.x, 163.x).
• neurocritical care admission due to intubation and controlled ventilation Stay ≥ 4 days at the ICU.
• Hospital stay on NICU of a minimum of 4 days.

Exclusion criteria

Patients who received initial do-not-treat/do-not-resuscitate (DNT/DNR) orders as well as those who deceased within 24 hours after admission were not enrolled

Trial design

474 participants in 1 patient group

Patients with stroke admitted to an NICU

Description:

Patients with neurovascular disease necessitating NICU-treatment. Neurovascular disease includes all stroke subcategorized into ischemic stroke and hemorrhagic stroke (i.e. subarachnoid hemorrhage and intracerebral hemorrhage)

Treatment:

Diagnostic Test: Time in therapeutic range of vital parameters