Traumatic Brain InjuryLong PAxNCT05043545
Long Pressure Autoregulation Index
An observational study of Traumatic Brain Injury, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 263 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
- Availability of continuous intensive care monitoring of physiological data.
Who cannot join
- Patients with less than 8 hours of physiological data monitoring.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months
Measured: 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).
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo GRITTI, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043545
- Sponsor's protocol ID
- PapaGiovanni H
- Acronym
- Long PAx
- Status last verified
- May 2024
- First submitted
- 29 Aug 2021
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Jun;44(3):900-913. doi: 10.1007/s12028-025-02429-4. Epub 2026 Jan 8.
PubMed 41507673Gritti 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.
PubMed 40120011Bonfanti M, Lorini FL, Zangari R, Bonanomi E, Farina A, Pezzetti G, Gerevini S, Aresi S, Dell'Avanzo G, Micheli F, Lanterna LA, Biroli F, Gritti P. Intracranial Pressure Thresholds for Cerebral Autoregulation Impairment: Age-Stratified Analysis of Ultra-Low-Frequency Pressure Reactivity Index (UL-PRx) in Traumatic Brain Injury. Neurocrit Care. 2025 Feb;42(1):152-163. doi: 10.1007/s12028-024-02056-5. Epub 2024 Jul 15.
PubMed 39009939Gritti 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.
PubMed 38263241Gritti 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.
PubMed 36847979
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05043545
- Acronym / sponsor ID
- Long PAx / PapaGiovanni H
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of acute neurological injury requiring intracranial pressure (ICP) monitoring.
- Availability of continuous intensive care monitoring of physiological data.
Key exclusion criteria (1 listed)
- Patients with less than 8 hours of physiological data monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality
Time frame: 12-months
The binary outcome of mortality (dead vs alive) during hospitalization and at 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Derived from this study: PubMed 41507673Gritti 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 Jun;44(3):900-913. doi: 10.1007/s12028-025-02429-4. Epub 2026 Jan 8.
- Derived from this study: PubMed 40120011Gritti 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.
- Derived from this study: PubMed 39009939Bonfanti M, Lorini FL, Zangari R, Bonanomi E, Farina A, Pezzetti G, Gerevini S, Aresi S, Dell'Avanzo G, Micheli F, Lanterna LA, Biroli F, Gritti P. Intracranial Pressure Thresholds for Cerebral Autoregulation Impairment: Age-Stratified Analysis of Ultra-Low-Frequency Pressure Reactivity Index (UL-PRx) in Traumatic Brain Injury. Neurocrit Care. 2025 Feb;42(1):152-163. doi: 10.1007/s12028-024-02056-5. Epub 2024 Jul 15.
- Derived from this study: PubMed 38263241Gritti 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.
- Derived from this study: PubMed 36847979Gritti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05043545, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.