Long Pressure Autoregulation Index

NCT ID: NCT05043545

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

263 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-10-01

Brief Summary

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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

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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).

Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papa Giovanni XXIII Hospital

OTHER

Sponsor Role lead

Responsible Party

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Paolo GRITTI

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Paolo Gritti

Bergamo, , Italy

Site Status

Countries

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Italy

References

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Gritti P, Bonfanti M, Zangari R, Bonanomi E, Di Matteo M, Corbella D, Farina A, Lecchi L, Togni T, Mandelli P, Lanterna LA, Biroli F, Lorini FL. Continuous monitoring of intracranial pressure and end tidal carbon dioxide variations in traumatic brain injury: introducing the carbon dioxide reactivity index (CO2Rx). J Clin Monit Comput. 2025 Jun;39(3):581-594. doi: 10.1007/s10877-025-01285-z. Epub 2025 Mar 22.

Reference Type DERIVED
PMID: 40120011 (View on PubMed)

Gritti P, Bonfanti M, Zangari R, Bonanomi E, Farina A, Pezzetti G, Pelliccioli I, Longhi L, Di Matteo M, Viscone A, Lando G, Cavalleri G, Gerevini S, Biroli F, Lorini FL. Cerebral autoregulation in traumatic brain injury: ultra-low-frequency pressure reactivity index and intracranial pressure across age groups. Crit Care. 2024 Jan 23;28(1):33. doi: 10.1186/s13054-024-04814-5.

Reference Type DERIVED
PMID: 38263241 (View on PubMed)

Gritti P, Bonfanti M, Zangari R, Bonanomi E, Pellicioli I, Mandelli P, Longhi L, Rasulo FA, Bertuetti R, Farina A, Biroli F, Lorini FL. Evaluation and application of ultra-low-frequency pressure reactivity index in pediatric traumatic brain injury patients. Acta Neurochir (Wien). 2023 Apr;165(4):865-874. doi: 10.1007/s00701-023-05538-1. Epub 2023 Feb 27.

Reference Type DERIVED
PMID: 36847979 (View on PubMed)

Other Identifiers

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PapaGiovanni H

Identifier Type: -

Identifier Source: org_study_id

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