Long Pressure Autoregulation Index

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT05043545
• Lead Sponsor: Papa Giovanni XXIII Hospital

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).

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-09-04
• Study First Posted: 2021-09-14
• Primary Completion: 2021-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale - Extended (GOSE)	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	12-months	The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months

Trial Locations

Locations (1)

Paolo Gritti; 🇮🇹 Bergamo, Italy