Evaluation and Application of Experimental Indices for the Study of Potential Prognostic Factors in Patients With Acute Neurological Injury, Using Low-frequency Sampled Data
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Papa Giovanni XXIII Hospital
- Enrollment
- 263
- Locations
- 1
- Primary Endpoint
- Glasgow Outcome Scale - Extended (GOSE)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The pressure reactivity index (PRx) has emerged as a surrogate method for the continuous bedside estimation of global cerebral autoregulation and a significant predictor of unfavorable outcomes. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICUs with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10-second average data as performed by the PRx, have been proposed.
The study aims to test new physiological indices appropriately modified to adapt to the scarcity of output data generated by standard hospital systems (frequency ~0.0033 Hz, approximately a 5-minute period) and to evaluate their association with outcome measures.
Detailed Description
Data preparation and index calculations were performed using an in-house algorithm. Data extracted and processed with the algorithm: Ultra-low pressure reactivity index (UL-PRx), Intracranial pressure (ICP), Cerebral perfusion pressure (CPP), Arterial blood pressure (ABP), heart rate (HR), respiratory rate (RR), temperature, end-tidal CO2 (EtCO2), saturation (SpO2).
Investigators
Paolo GRITTI
Principal Investigator
Papa Giovanni XXIII Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
- •Availability of continuous intensive care monitoring of physiological data.
Exclusion Criteria
- •Patients with less than 8 hours of physiological data monitoring.
Outcomes
Primary Outcomes
Glasgow Outcome Scale - Extended (GOSE)
Time Frame: 12-months
The global functional outcome at 12 months assessed by Glasgow Outcome Scale-Extended (GOS-E), dichotomized into favorable (a score of 5-6 defines a score of 5 to 8, Moderate Disability) and unfavorable (a score of 1 to 4, Dead is characterized by a score of 1).
mortality
Time Frame: 12-months
The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months