Long Pressure Autoregulation Index

NCT05043545 | Completed

• 1 other identifier: PapaGiovanni H
• Study Type: observational
• Target: 263
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• mortality

  The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months

  12-months

• 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

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
• Availability of continuous intensive care monitoring of physiological data.

You may not qualify if:

• Patients with less than 8 hours of physiological data monitoring.

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Paolo Gritti

Bergamo, 24127, Italy

Location

Related Publications (4)

• Gritti P, Bonfanti M, Zangari R, Bonanomi E, Di Matteo M, Dell'Avanzo G, Corbella D, Micheli F, Lanterna LA, Lando G, Pezzetti G, Vascello MF, Biroli F, Lorini FL. Visualizing and Interpreting the Carbon Dioxide Reactivity Index in Traumatic Brain Injury. Neurocrit Care. 2026 Jan 8. doi: 10.1007/s12028-025-02429-4. Online ahead of print.

  PMID: 41507673 DERIVED

• 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.

  PMID: 40120011 DERIVED

• 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.

  PMID: 38263241 DERIVED

• 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.

  PMID: 36847979 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2021
• First Posted: September 14, 2021
• Study Start: March 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)