- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06192342
Ventilatory Parameters in Acute Neurological Injury
Baseline Ventilatory Parameters in Patients With Acute Neurological Injury
The goal of this observational study is to test the association between baseline ventilatory parameters (in particular mechanical power (MP), mechanical power normalized to predicted body weight (MP/PBW) and driving pressure (DP) with the baseline neurological status (assessed through the Glasgow coma score) in adults patients under mechanical ventilation with acute neurological injury secondary to stroke, brain trauma or subarachnoid hemorrhage.
The main question[s]it aims to answer are:
- In patients with acute neurological injury under mechanical ventilation, is there a correlation between the acute neurological injury, assessed using the Glasgow scale on admission, and baseline ventilatory parameters?
- In patients with acute neurological injury under mechanical ventilation, are the baseline ventilatory parameters altered at baseline?
Study Overview
Status
Detailed Description
Adults patients with acute neurological injury (ANI) secondary to stroke, brain trauma or subarachnoid hemorrhage may present extraneurological complications. They occur as a consequence of the release of inflammatory mediators in an altered blood-brain barrier, which reach the circulation and thus alter the functionality of other organs. Of the affected organs, the lung is the most frequently compromised, leading to increased morbidity, mortality, and worse neurological outcomes. It should be noted that a large proportion of patients with ANI require mechanical ventilation (MV), which also through the production of inflammatory mediators, can lead to the development of ventilator-induced lung injury (VILI) and alteration of other organs.
From the above, it can be thought that in patients with ANI, the basal respiratory parameters could be altered and this is important, given that in this group of patients, the ventilatory parameters could generate changes at the brain level, particularly an increase in intracranial pressure (ICP) and variation in PaCO2 that would produce changes in the vasculature and concomitantly in cerebral blood flow. In turn, the use of protective ventilation, recommended in other pathologies such as acute respiratory distress syndrome (ARDS), is not clearly defined for this group of patients. For this reason, the objective of this study is the assessment of baseline ventilatory parameters in patients with ANI, in particular mechanical power (MP), mechanical power normalized to predicted body weight (MP/PBW) and driving pressure (DP) and to determine their association with the baseline neurological status (assessed through the Glasgow coma score). The hypothesis of the study, assuming that the greater the initial neurological damage, the greater the ventilatory alterations, is that MP correlates with the degree of neurological injury. The second hypothesis is that ventilatory variables, particularly MP, are altered at baseline in patients with LNA.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Roberto S Cruz, Dr.
- Phone Number: +5492966559019
- Email: resc.hrrg@gmail.com
Study Locations
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, B6600KCL
- Recruiting
- Roberto Santa Cruz
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Contact:
- Roberto Santa Cruz, Dr.
- Phone Number: +5492966559019
- Email: resc.hrrg@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Acute neurological injury in patients ≥ 16 years of age with requiring mechanical ventilation for neurological causes and without baseline lung injury, defined as: normal chest x-ray and adequate oxygenation; PaO2/FiO2 ≥ 300.
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Exclusion Criteria:
Pneumothorax, or a pleural drainage tube. Hemodynamic instability (mean blood pressure ≤ 65 mmHg) or high doses of inotropes (Norepinephrine > 0.5 gammas/kilo/minute or equivalent).
PaO2/FiO2 < 80 mmHg. Chronic obstructive pulmonary disease (COPD). Pregnant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with acute neurological injury
Patients ≥ 16 years of age with ANI requiring mechanical ventilation for neurological causes, without baseline lung injury, defined by a PaO2/FiO2 ≥ 300 and with a normal chest x-ray
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between acute neurological injury and mechanical power normalized to predicted body weight
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
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To determine the degree of correlation between acute neurological injury, assessed using the Glasgow coma score [GCS; with a score between 3 (worst score, most severe) and 15 (best score, least severe)] and mechanical power normalized to predicted body weight (Joules/minute/kilograms)
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The first 2 days of the patient on mechanical ventilation (MV)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between acute neurological injury and mechanical power
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To determine the degree of correlation between acute neurological injury, assessed using the Glasgow coma score [GCS; with a score between 3 (worst score, most severe) and 15 (best score, least severe)] and mechanical power (Joules/minute)
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The first 2 days of the patient on mechanical ventilation (MV)
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Correlation between acute neurological injury and ΔP
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To determine the degree of correlation between acute neurological injury, assessed using the Glasgow coma score [GCS; with a score between 3 (worst score, most severe) and 15 (best score, least severe)] and ΔP (centimeter of water)
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess static pressure
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the static pressure: Pplat (centimeter of water)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess the respiratory system resistance
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the respiratory system resistance: it is the relationship between the difference between peak pressure and static pressure with the inspiratory flow: R = (Ppeak-Pplat)/Inspiratory flow (centimeter of water/liters/second)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess the driving pressure
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the driving pressure: it is the difference between static pressure and PEEP: ΔP = Pplat-PEEP (centimeter of water)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess the static compliance
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the static compliance: it is the relationship between tidal volume and ΔP (mililiters/centimeter of water)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess the dynamic driving pressure
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the dynamic driving pressure: it is the difference between peak pressure and PEEP: ΔP = Ppeak-PEEP (centimeter of water), (centimeter of water)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess mechanical power normalized to predicted body weight
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
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To assess the mechanical power normalized to predicted body weight (Joules/minute/kilograms)
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The first 2 days of the patient on mechanical ventilation (MV)
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To assess the static pressure according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the static pressure (centimeter of water) according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the respiratory system resistance according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the respiratory system resistance (it is the relationship between the difference between peak pressure and static pressure with the inspiratory flow) (centimeter of water/liters/seconds), according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the driving pressure according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the driving pressure (it is the difference between static pressure and PEEP) (centimeter of water), according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the static compliance according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the static compliance (it is the relationship between tidal volume and ΔP) (mililiters/centimeter of water), according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the dynamic driving pressure according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the dynamic driving pressure (it is the difference between peak pressure and PEEP) (centimeter of water), according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the mechanical power normalized to predicted body weight according to the different subgroups of ANI
Time Frame: The first 2 days of the patient on mechanical ventilation (MV)
|
To assess the mechanical power normalized to predicted body weight (Joules/minute/kilograms) according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
|
The first 2 days of the patient on mechanical ventilation (MV)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roberto Santa Cruz, Hospital General Ramos Mejia
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Craniocerebral Trauma
- Intracranial Hemorrhages
- Brain Injuries
- Wounds and Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Subarachnoid Hemorrhage
- Trauma, Nervous System
Other Study ID Numbers
- Observational
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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