A New Approach in Intensive Care Unit Consciousness Assessment: FIVE Score

NCT06036732 | Unknown

• 1 other identifier: E-72109855-604.01.01-7591
• Study Type: observational
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.The primary aim of this study is to investigate the correlation between the length of ICU stay and a newly developed FIVE score in neuro-intensive care patients.
2. 2.The secondary objectives are to evaluate the impact of the FIVE score on hospital length of stay, Modified Rankin Scale, and mortality, as well as to determine the correlation between the GCS, FOUR, and FIVE scores

Conditions

Postoperative Intracranial Hematoma; Postoperative Intracranial Haemorrhage; Supratentorial Cancer; Infratentorial Neoplasms; Arnold Chiari Malformation; Subarachnoid Hemorrhage; Traumatic Brain Injury; Epilepsy, Temporal Lobe; Cerebrovascular Event; Intensive Care Neurological Disorder; Coma; Unconsciousness; Assessment, Self

Keywords

FIVE Score; FOUR Score; GCS; Modified Rankin Score; Neuro-ICU

Outcome Measures

Primary Outcomes (3)

• Change in FIVE Scores

  Full Intracranial Validity Evaluation, minimum value:0, maximum value: 20, higher scores mean a better situation

  baseline, 12 hours intervals, up to an hour of ICU discharge

• Change in GKS Scores

  Glasgow Coma Score, minimum value:3, maximum value: 15, higher scores mean a better situation

  baseline, 12 hours intervals, up to an hour of ICU discharge

• Modified Rankin Scale

  In scoring post-discharge morbidity six months after intensive care unit discharge, Modified Rankin Score is used. minimum value:0, maximum value:6, higher scores mean a worse outcome

  six months after ICU discharge

Other Outcomes (2)

• Length of stay in ICU

  From hospitalization to hospital discharge, estimated average = 10 days

• Length of stay in hospital

  From hospitalization to hospital discharge, estimated average = 10 days

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients between the ages of 18 and 80, who were monitored in the Neurosurgical Intensive Care Unit and had a history of ischemic or hemorrhagic stroke within the last 6 months, underwent infratentorial craniotomy, supratentorial craniotomy, endoscopic surgery, vascular surgery, epilepsy surgery, hydrocephalus surgery, or neurovascular intervention, were included in the study

You may qualify if:

• between the ages of 18 and 80
• who were monitored in the Neurosurgical Intensive Care Unit
• had a history of ischemic or hemorrhagic stroke within the last 6 months
• underwent infratentorial craniotomy
• supratentorial craniotomy
• endoscopic surgery
• vascular surgery
• epilepsy surgery
• hydrocephalus surgery
• neurovascular intervention

You may not qualify if:

• patients over 80 years of age
• under 18 years of age
• patients who were sedated
• patients who were administered neuromuscular blockers during intensive care follow-up
• patients with diagnosed psychiatric illness
• patients who were alcohol or drug addicts

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa(IUC)

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Supratentorial Neoplasms; Infratentorial Neoplasms; Arnold-Chiari Malformation; Subarachnoid Hemorrhage; Brain Injuries, Traumatic; Epilepsy, Temporal Lobe; Coma; Unconsciousness

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Epilepsies, Partial; Epilepsy; Epileptic Syndromes; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ozlem Korkmaz Dilmen, MD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Yusuf Tunali, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Fatma Eren Akcil, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Merve Tugba Ozfidan Donmez, MD

CONTACT

00905056444156; mtozfidann@gmail.com

Ozlem Korkmaz Dilmen, MD

CONTACT

00905325801520; korkmazdilmen@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: September 14, 2023
• Study Start: October 1, 2023
• Primary Completion: January 25, 2024
• Study Completion: February 25, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

TU (1)