Validation of the FOUR Coma Scale in Russia.

NCT04018989 | Completed

• 1 other identifier: FARCT0002
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to examine the validity of the Russian version of the FOUR Full Outline of UnResponsiveness (hereafter FOUR) scale in adult ICU patients with an acute cerebral insufficiency clinic (hereinafter referred to as OTSN). Compare the accuracy and predictive significance of FOUR when used by an ICU specialist, a neurologist, nursing staff, during bedside and telemedicine Examinations.

Conditions

Stroke; Traumatic Brain Injury; Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• The interrater reliability of russian rendition the FOUR score

  Correlation of the results of the inspection carried out by GSC FOUR by one and the same specialist. The Full Outline of UnResponsiveness (FOUR) coma scale is used to grade coma depth in intubated patients. The FOUR coma scale includes 4 parameters with a minimum score of 0 and a maximum score of "4" for each of them: eye reactions (eye opening and tracking), motor responses (pain response and simple commands), stem reflexes (pupillary, corneal and cough) ) and respiratory patterns (respiratory rhythm and respiratory attempts in patients on a ventilator). The points are summed up, their sum is estimated. Interpretation of the results Result Scored Clear consciousness 15 - 16 Impairment of consciousness - less than 15 Coma from 4 to 8 Brain death 0-4

  1 day after admission to the hospital

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.
• cardiopulmonary resuscitation
• arterial hypotension
• hypoxemia
• malignant hyperthermia or hypothermia

Sponsors & Collaborators

• Russian Federation of Anesthesiologists and Reanimatologists: lead

Study Sites (3)

Krasnodar regional hospital №2 (Kuban State Medical University)

Krasnodar, Russia

Location

Clinical city hospital № 40

Yekaterinburg, Russia

Location

Sverdlovsk Regional Clinical Hospital № 1

Yekaterinburg, Russia

Location

Related Publications (17)

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MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrey Belkin, MD

  CEO Clinical Institute of Brain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: July 20, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 10, 2019
• Last Updated: September 25, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)