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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06036732
Other study ID # E-72109855-604.01.01-7591
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date February 25, 2024

Study information

Verified date September 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Merve Tugba Ozfidan Donmez, MD
Phone 00905056444156
Email mtozfidann@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 223
Est. completion date February 25, 2024
Est. primary completion date January 25, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Locations

Country Name City State
Turkey Istanbul University- Cerrahpasa(IUC) Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Length of stay in ICU Length of neuro ICU follow-up period From hospitalization to hospital discharge, estimated average = 10 days
Other Length of stay in hospital Length of hospital follow-up period From hospitalization to hospital discharge, estimated average = 10 days
Primary 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
Primary 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
Primary 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
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