Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06043167 |
| Other study ID # |
523721 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2023 |
| Est. completion date |
May 30, 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Surgut Clinical Trauma Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to increase the effectiveness of clinical monitoring of patients
with acute cerebral insufficiency by improving the discriminative ability of the FOUR scale.
To study the sensitivity and specificity of the FOUR scale as a clinimetric of chronic
disorders of consciousness.
Description:
The key step in choosing a strategy for treating acute cerebral insufficiency is the
assessment of the severity of cerebral damage and prognosis. The importance of correcting the
severity of damage and prognosis for the choice of treatment strategy is beyond doubt.
At the same time, the complexity of objective evaluation is preserved throughout the world,
after more than 40 years, has become an integral part of clinical practice worldwide. The
findings obtained using GCS showed a strong relationship with those obtained using other
indicators of severity and outcome. Although the scale of Glasgow coma is considered routine
method, it has a number of significant drawbacks.
First, the verbal response of GCS tests often becomes inadequate in psychomotor-excited
patients. On the contrary, in many patients with depressed consciousness, the verbal response
is insufficient. Moreover, the GSC verbal response assessment cannot be applied to critical
patients or those who have undergone intubation.
Secondly, and most importantly, GSC does not assess brain stem reflexes, eye movements, or
complex motor responses in patients with altered consciousness. In addition, the GCS score is
numerically skewed toward the motor response (the maximum number of points given for the
motor response). These deficiencies previously caused repeated attempts to improve GCS:
reaction level scale (RLS85), comprehensive consciousness level Scale (CLOCS), clinical
neurological assessment (CNA) , Coma Recovery Scale (CRS), Glasgow-Liege Scale (GLS),
Innsbruck Coma Scale (ICS), 15 and 60-second test (SST). Similar scans, tests are very long
and laborious. None of these subsequently gained enough weight to replace GCS.
Third, despite the fact that GSC is regularly used in therapeutic and surgical intensive care
units and resuscitation units, as well as the fact that it is usually used in conjunction
with the APACHE system assessment, reliability in predicting outcomes in patients is
unsatisfactory. Fourthly, Rowley and Fielding found that the reliability of the GCS score
increases with the experience of its users and that user inexperience is associated with a
high error rate.
The new coma scale, Full Outline of UnResponsiveness (FOUR), is based on the minimum number
of tests needed to analyze the severity of cerebral damage and prognosis. Universal and
suitable, including for patients with altered consciousness. The FOUR scale has four
categories studied. In contrast to GCS, the number of components and the maximum rating in
each category are four (E4, M4, B4, R4). This is significantly easier than in GCS with
different points for each category. The FOUR scale is suitable for assessing a patient with a
locked person syndrome, as well as in the presence of a vegetative state. Conditions when the
eyes can open spontaneously, but cannot follow the pointer. The motor or motor component is
recorded primarily on the limb. Response options include the presence of status epilepticus,
myoclonus. Also, the motor response combines decorticative regimen and generalized myoclinic
status. Hand position tests (thumb up, fist, and peace sign) are reliable for assessing
wakefulness. Three reflexes assessing brain stem depression, testing the functions of the
midbrain, pons and medulla oblongata, are used in various combinations. The clinical sign of
acute dysfunction of the third pair of FMN (unilateral pupil dilation), pupillary and
oculomotor reactions is assessed. Separately, the functioning of the respiratory center, as
the lower part of the brain stem, is considered. In intubated patients, the presence of
independent attempts between cycles of mechanical ventilation is assessed. The value of 0 in
all responses is the basis for considering the diagnosis of brain death. The FOUR evaluation
of the lung is reproducible and takes several minutes.
In order to increase the effectiveness of clinical monitoring of patients with acute cerebral
insufficiency by improving the discriminatory ability of the FOUR scale, and to study the
sensitivity and specificity of the scale as clinimetrics of chronic disorders of
consciousness, a study was initiated: Clinimetric application of FOUR scale as in treatment
and rehabilitation of patients with Acute Cerebral Injury - FOURACI.
The aim of this study is to increase the effectiveness of clinical monitoring of patients
with acute cerebral insufficiency by improving the discriminative ability of the FOUR scale.
To study the sensitivity and specificity of the FOUR scale as a clinimetric of chronic
disorders of consciousness.
A monocenter prospective non-randomized cohort study is planned using a continuous sampling
method on the basis of the Surgut Clinical Trauma Hospital of the Khanty-Mansiysk Autonomous
Okrug - Yugra in the department of anesthesiology - intensive care, ICU for patients with
chronic impaired consciousness and the department of medical rehabilitation of patients with
CNS disorders.
The objectives of the study are:
1. To investigate the sensitivity of FOUR in the range of values <8 to the dynamics of the
state in comparison with the GCS scale and the unified interdisciplinary scale of
disorders of consciousness (A.N.Konovalova).
2. Stratify the ranges of values of the FOUR scale from the position of outcomes according
to GOS and PITC in ICU patients with different resuscitation syndromes.
3. Calibrate the FOUR scale to assess the prognosis of the outcome of the course of the OCN
in the acute (in ICU patients) and subacute (rehabilitation department) period.
It is planned to include at least 200 adult OAR patients and all those transferred to the
rehabilitation department for evaluation.
To maintain accounting documentation, an individual registration card is offered for
registration. The paper version of the IRC records the age of the patient, the diagnosis
according to the International Classification of diseases of the tenth revision (ICD-10), the
day of hospital stay and ICU. The level of consciousness is assessed according to the unified
interdisciplinary scale of disorders of consciousness, Glasgow Coma Scale (GCS), Full Outline
of Unresponsiveness (FOUR) and Richmond Agitation-Sedation Scale (RASS). The severity of the
patient's condition is assessed according to the scales: comorbidity Index, Behavior Pain
Assessment (BPS), Acute Physiology and Chronic Health Evaluation II (APACHE II),
Sepsis-related Organ Failure Assessment (SOFA), Glasgow Outcome Scale (GOS). After each
inspection, the data is entered into the electronic version of the IRC.
