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Long Pressure Autoregulation Index

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05043545
Acronym
Long PAx
Enrollment
263
Registered
2021-09-14
Start date
2021-03-01
Completion date
2023-10-01
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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).

Interventions

None listed

Sponsors

Papa Giovanni XXIII Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
mortality12-monthsThe binary outcome of mortality (dead vs alive) during hospitalization and at 12-months
Glasgow Outcome Scale - Extended (GOSE)12-monthsThe 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).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026