UL-PRx: Ultra Low-Resolution Pressure Reactivity Index in Moderate or Severe Traumatic Brain Injury

Sponsor

Papa Giovanni XXIII Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05043545

Collaborator

(none)

210

Enrollment

Location

Actual Duration (Months)

29.9

Patients Per Site Per Month

Study Details

Study Description

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 outcome. However, calculations require continuous, high-resolution monitoring and are currently limited to specialized ICU with dedicated software. To overcome this problem, new indices calculated using one-minute average data, instead of 10 seconds average data as performed by the PRx, has been proposed. The study aims to test some indexes appropriately modified to adapt to the scarcity of output data generated by standard hospital systems by analyzing the effectiveness of the Ultra Low-frequency Pressure Reactivity index (UL-PRx sampled at ~0.0033 Hz, about 5 minutes period) to evaluate association with outcome. The results indicate that sampling at ultra-low frequency might be of enough resolution to derive information about the state of cerebrovascular autoregulation and outcome of TBI patients. Indexes significantly associated with outcome, as UL-PRx, open new research fields between static and dynamic autoregulation, expanding the possibilities of investigation in TBI.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury

Detailed Description

Participants will be grouped into 2 cohorts by age: child cohort (0 - 17 years old), adult cohort (≥18 years old).

Study Design

Study Type:

Observational

Actual Enrollment :

210 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Evaluation and Application of Ultra Low-Resolution Pressure Reactivity Index in Moderate or Severe Traumatic Brain Injury

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Outcome Measures

Primary Outcome Measures

mortality [12-months]
The binary outcome of mortality (dead vs alive) during hospitalization and at 12-months
Glasgow Outcome Scale - Extended (GOSE) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of TBI
The availability of continuous intensive care monitoring of physiological data (ICP, MAP, and CPP).

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Paolo Gritti	Bergamo		Italy	24127

Sponsors and Collaborators

Papa Giovanni XXIII Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paolo GRITTI, Principal Investigator, Papa Giovanni XXIII Hospital

ClinicalTrials.gov Identifier:

NCT05043545

Other Study ID Numbers:

PapaGiovanni H

First Posted:

Sep 14, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Nov 18, 2021