Long Pressure Autoregulation Index

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

1 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Paolo Gritti

Bergamo, 24127, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

mortality

Time frame: 12-months

The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months
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).

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

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

Acronym: Long PAx

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2023
First posted: Sep 14, 2021
Registry last updated: May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed