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NCT Number: NCT06192342

Ventilatory Parameters in 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:

1. 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? 2. In patients with acute neurological injury under mechanical ventilation, are the baseline ventilatory parameters altered at baseline?

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Key information

Conditions

Neurologic Decompensation, Acute Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roberto Santa Cruz

Ciudad Autonoma de Buenos Aires, Buenos Aires, B6600KCL, Argentina

Location status: Recruiting

Location contact

Roberto Santa Cruz, Dr.

CONTACT

[email protected]

+5492966559019

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.Neumovent TS and Neumovent Advance respirators will be used.

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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

Treatment and study plan

Primary outcomes

  1. 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)

    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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. To assess mechanical power normalized to predicted body weight

    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)

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonella Civile, Dr.

CONTACT

[email protected]

Roberto S Santa Cruz, Dr.

CONTACT

[email protected]

+5492966559019

Sponsors and collaborators

Lead sponsor

Ramos Mejía Hospital

Other

Registry information

Official study title

Baseline Ventilatory Parameters in Patients With Acute Neurological Injury

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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