Long Pressure Autoregulation Index

Traumatic Brain Injury Clinical Trial

— Long PAx  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05043545
• Other study ID #: PapaGiovanni H
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2024
• Source: Papa Giovanni XXIII Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
Italy	Paolo Gritti	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Papa Giovanni XXIII Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months	12-months
Primary	Glasgow Outcome Scale - Extended (GOSE)	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