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

NCT06043167 | Unknown

• 1 other identifier: 523721
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Acute Traumatic Brain Injury; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The interrater reliability of russian rendition the FOUR score

  2023 - 2024

Other Outcomes (1)

• The predictive value russian rendition the FOUR score.

  2023 - 2024

Interventions

The predictive value russian rendition the FOUR score. DIAGNOSTIC_TEST

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.

Eligibility Criteria

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

Study Population

Adult atients with syndrome of acute cerebral insufficiency

You may qualify if:

• acute brain failure after stroke or acute brain trauma

You may not qualify if:

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

Sponsors & Collaborators

• Surgut Clinical Trauma Hospital: lead
• Ural State Medical University: collaborator

Study Sites (1)

Surgut Clinical Trauma Hospital

Surgut, Khanty-Mansi Autonomous Okrug - Yugra, 628400, Russia

Location

MeSH Terms

Conditions

Stroke; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrey Belkin

  Russian Federation of Anesthesiologists and Reanimatologists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MDRussian Federation of Anesthesiologists and Reanimatologists

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 8, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)