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Not yet recruitingNCT06036732Updated Sep 14, 2023

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

An observational study in Postoperative Intracranial Hematoma, Postoperative Intracranial Haemorrhage and Supratentorial Cancer, sponsored by Istanbul University - Cerrahpasa. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-14.

Sponsored by Istanbul University - Cerrahpasa · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
223
Ages
18 Years to 80 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • 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
03

In context

Supratentorial Neoplasms

22 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.

Browse Supratentorial Neoplasms studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
223 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Change in FIVE Scores

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

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

  2. Change in GKS Scores

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

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

  3. 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

    Time frame: six months after ICU discharge

Other outcomes

  1. Length of stay in ICU

    Length of neuro ICU follow-up period

    Time frame: From hospitalization to hospital discharge, estimated average = 10 days

  2. Length of stay in hospital

    Length of hospital follow-up period

    Time frame: From hospitalization to hospital discharge, estimated average = 10 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — Glasgow Coma Scale (GCS) and Four/Five Scores, along with the highest, lowest, and average scores, discharge scores, Modified Rankin Scores at 6 months post-discharge, and length of stay information measured upon admission to the intensive care unit will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06036732
Responsible party
merve tugba ozfidan donmez (medical doctor, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Sep 14, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Jan 25, 2024 (estimated)
Completion
Feb 25, 2024 (estimated)
Last update
Sep 14, 2023

Study contacts

Merve Tugba Ozfidan Donmez, MD
Contact
mtozfidann@gmail.com
00905056444156
Ozlem Korkmaz Dilmen, MD
Contact
korkmazdilmen@gmail.com
00905325801520
Ozlem Korkmaz Dilmen, MD
study chair · Istanbul University - Cerrahpasa
Yusuf Tunali, MD
study director · Istanbul University - Cerrahpasa
Fatma Eren Akcil, MD
study director · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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