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

NCT ID: NCT06036732

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 223 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-02-25

Brief Summary

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. 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

Detailed Description

Consciousness monitoring is crucial in neuro-intensive care. Despite the use of different scoring systems to establish a common language among evaluators, the Glasgow Coma Scale (GCS) remains the most widely used in clinical practice. In GCS evaluation, verbal response, motor response, and eye response are assessed. Another scoring system, FOUR (Full Outline of UnResponsiveness ) Score is similar to the Glasgow Coma Score (GCS). But it is designed to provide a more comprehensive neurological assessment. The FOUR score evaluates four areas: including eye opening, motor response, brainstem reflexes, and respiration, and assigns a score for each area. A comprehensive education regarding those scores was given the intensive care healthcare providers before the trial.

In this study, the investigators developed the Full Intracranial Validity Evaluation (FIVE) Score, by adding the mean arterial pressure and gag reflex components to the FOUR score. The investigators believe that this new score, which can be used for clinical monitoring, may offer an alternative to FOUR and GCS monitoring. According to this scoring system, in addition to the criteria for the FOUR score, patients with a mean arterial pressure between 60-130mmHg receive 2 points; patients under inotropic support with a mean arterial pressure between 60-130mmHg receive 1 point; patients with a mean arterial pressure below 60mmHg or above 130mmHg receive 0 points. Additionally, for patients with infratentorial mass, the investigators add the assessment of gag reflex in the calculation of the FIVE score. If the reflex is absent, 0 points are given; if it is unilateral, 1 point is given, and if it is preserved, 2 points are given.

The demographic data, diagnoses, systemic comorbidities, the American Society of Anaesthesiologists (ASA) score, the Charlson Comorbidity Index (CCI), and the APACHE II scores of patients were recorded.

The GCS, FOUR, and FIVE scores of the patients were recorded at neuro ICU admission, every 12 hours during neuro ICU follow-up period and discharge. In our clinic, GCS monitoring is routinely performed hourly for every patient admitted to the ICU. For patients with a decrease of two or more points in GCS score, FOUR and FIVE scores were re-evaluated and recorded without waiting for the 12 hours. Besides this, the worst, the best and the mean GCS, FOUR, and FIVE scores were recorded in the neuro ICU follow-up period. The assessment count of the GCS, FOUR, and FIVE scores during clinical follow-up was recorded.

The length of ICU and hospital stay were recorded. The Modified Rankin Scale of the patients was recorded six months after ICU discharge.

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. The secondary objectives are to evaluate the impact of the FIVE score on length of hospital 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

merve tugba ozfidan donmez

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozlem Korkmaz Dilmen, MD

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Yusuf Tunali, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Fatma Eren Akcil, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University- Cerrahpasa(IUC)

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Merve Tugba Ozfidan Donmez, MD

Role: CONTACT

mtozfidann@gmail.com

00905056444156

Ozlem Korkmaz Dilmen, MD

Role: CONTACT

korkmazdilmen@gmail.com

00905325801520

Facility Contacts

Merve Tugba Ozfidan Donmez, MD

Role: primary

mtozfidann@gmail.com

00905056444156

Other Identifiers

E-72109855-604.01.01-7591

Identifier Type: -

Identifier Source: org_study_id