CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 263 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT05043545
NCT05043545N/ACompleted

Evaluation and Application of Experimental Indices for the Study of Potential Prognostic Factors in Patients With Acute Neurological Injury, Using Low-frequency Sampled Data

Papa Giovanni XXIII Hospital·observational·Posted Sep 14, 2021·Updated May 6, 2024

In Brief

An observational study for Traumatic Brain Injury. Completed, enrolled 263 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 14, 2021
Enrollment StartMar 1, 2021
Primary CompletionOct 1, 2021
Study CompletionOct 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.8 years ago