Ventilatory Parameters in Acute Neurological Injury

Stroke Clinical Trial

Official title:

Baseline Ventilatory Parameters in Patients With Acute Neurological Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192342
• Other study ID #: Observational
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: May 30, 2027

Study information

• Verified date: June 2024
• Source: Ramos Mejía Hospital
• Contact: Roberto S Cruz, Dr.
• Phone: +5492966559019
• Email: resc.hrrg[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: May 30, 2027
• Est. primary completion date: May 30, 2025
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemorrhage
• Stroke
• Subarachnoid Hemorrhage
• Trauma, Nervous System
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Argentina	Roberto Santa Cruz	Ciudad Autonoma de Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Ramos Mejía Hospital

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between acute neurological injury and mechanical power normalized to predicted body weight	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)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	Correlation between acute neurological injury and mechanical power	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)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	Correlation between acute neurological injury and ?P	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 ?P (centimeter of water)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess static pressure	To assess the static pressure: Pplat (centimeter of water)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess the respiratory system resistance	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)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess the driving pressure	To assess the driving pressure: it is the difference between static pressure and PEEP: ?P = Pplat-PEEP (centimeter of water)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess the static compliance	To assess the static compliance: it is the relationship between tidal volume and ?P (mililiters/centimeter of water)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess the dynamic driving pressure	To assess the dynamic driving pressure: it is the difference between peak pressure and PEEP: ?P = Ppeak-PEEP (centimeter of water), (centimeter of water)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess mechanical power normalized to predicted body weight	To assess the mechanical power normalized to predicted body weight (Joules/minute/kilograms)	The first 2 days of the patient on mechanical ventilation (MV)
Secondary	To assess the static pressure according to the different subgroups of ANI	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)
Secondary	To assess the respiratory system resistance according to the different subgroups of ANI	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)
Secondary	To assess the driving pressure according to the different subgroups of ANI	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)
Secondary	To assess the static compliance according to the different subgroups of ANI	To assess the static compliance (it is the relationship between tidal volume and ?P) (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)
Secondary	To assess the dynamic driving pressure according to the different subgroups of ANI	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)
Secondary	To assess the mechanical power normalized to predicted body weight according to the different subgroups of ANI	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)