Long Pressure Autoregulation Index (Long PAx)

May 2, 2024 updated by: Paolo GRITTI, Papa Giovanni XXIII Hospital

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

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 Overview

Status

Completed

Conditions

Traumatic Brain Injury

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 Type

Observational

Enrollment (Actual)

263

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Bergamo, Italy, 24127
    - Paolo Gritti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with acute neurological injury admitted to ICU of the ASST Papa Giovanni XXIII requiring ICP monitoring during the study period (January 2013 - June 2022). For Traumatic Brain Injury (TBI) it is estimated that medical records from approximately 210 TBI subjects requiring ICP monitoring will be reviewed. The final number of subjects to be included will be determined based on available medical records obtained within the timeframe of the estimated duration of the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality Time Frame: 12-months	The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months	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).	12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papa Giovanni XXIII Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

August 29, 2021

First Submitted That Met QC Criteria

September 4, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

PapaGiovanni H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.