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Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury (FOURACI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06043167
Recruitment Status : Active, not recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborator:
Ural State Medical University
Information provided by (Responsible Party):
Andrey Belkin, Ural State Medical University

Brief 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.

Condition or disease Intervention/treatment
Stroke Acute Traumatic Brain Injury Subarachnoid Hemorrhage Diagnostic Test: The predictive value russian rendition the FOUR score.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury. - a Prospective Observational Mono-center Cohort Study
Actual Study Start Date : September 8, 2023
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation


Intervention Details:
  • Diagnostic Test: The predictive value russian rendition the FOUR score.

    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). After each inspection, the data is entered into the electronic version of the IRC.



Primary Outcome Measures :
  1. The interrater reliability of russian rendition the FOUR score [ Time Frame: 2023 - 2024 ]

Other Outcome Measures:
  1. The predictive value russian rendition the FOUR score. [ Time Frame: 2023 - 2024 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Adult atients with syndrome of acute cerebral insufficiency
Criteria

Inclusion Criteria:

  • acute brain failure after stroke or acute brain trauma

Exclusion Criteria:

  • the inability to assess the factors included in the study.
  • cardiopulmonaryresuscitation
  • arterial hypotension
  • hypoxemia
  • malignant hyperthermia or hypothermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043167


Locations
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Russian Federation
Surgut Clinical Trauma Hospital
Surgut, Khanty-Mansi Autonomous Okrug - Yugra, Russian Federation, 628400
Sponsors and Collaborators
Surgut Clinical Trauma Hospital
Ural State Medical University
Investigators
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Principal Investigator: Andrey Belkin Russian Federation of Anesthesiologists and Reanimatologists
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Responsible Party: Andrey Belkin, MDRussian Federation of Anesthesiologists and Reanimatologists, Ural State Medical University
ClinicalTrials.gov Identifier: NCT06043167    
Other Study ID Numbers: 523721
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Hemorrhage
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases