Neurologic Decompensation, AcuteNCT06192342
Ventilatory Parameters in Acute Neurological Injury
An observational study of Neurologic Decompensation, Acute and Traumatic Brain Injury, run by Ramos Mejía Hospital at 1 site in Argentina.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neurologic Decompensation, Acute, Traumatic Brain Injury, Stroke
- How many people
- 19 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2024to 30 Jun 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: All patients ≥ 16 years of age with an ANI requiring mechanical ventilation for neurological causes.
Who may be able to join
- 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.
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antonella Civile, Dr. contact
Argentina1 site, 1 recruiting
- Recruiting
Roberto Santa Cruz
Ciudad Autonoma de Buenos Aires, Buenos Aires, B6600KCL
Roberto Santa Cruz, Dr., +5492966559019, resc.hrrg@gmail.com
About this study
Official title: 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?
Read the 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.
- Keywords
- acute neurological injury, mechanical ventilation
- Medical subject headings
- Brain Injuries, Traumatic, Stroke, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
Secondary outcomes (14)
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)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
Correlation between acute neurological injury and ΔP
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)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
To assess static pressure
To assess the static pressure: Pplat (centimeter of water)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
To assess the driving pressure
To assess the driving pressure: it is the difference between static pressure and PEEP: ΔP = Pplat-PEEP (centimeter of water)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
To assess the static compliance
To assess the static compliance: it is the relationship between tidal volume and ΔP (mililiters/centimeter of water)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
To assess the dynamic driving pressure
To assess the dynamic driving pressure: it is the difference between peak pressure and PEEP: ΔP = Ppeak-PEEP (centimeter of water), (centimeter of water)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
To assess mechanical power normalized to predicted body weight
To assess the mechanical power normalized to predicted body weight (Joules/minute/kilograms)
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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.
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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.
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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.
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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 ΔP) (mililiters/centimeter of water), according to the different subgroups of ANI: brain trauma injury (BTI), subarachnoid hemorrhage (SAH) and stroke.
Measured: The first 2 days of the patient on mechanical ventilation (MV)
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.
Measured: 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
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.
Measured: The first 2 days of the patient on mechanical ventilation (MV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 May 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic Decompensation, AcuteStudies 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
- Prospective
- Enrolment
- 19 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ramos Mejía Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Santa Cruz, Ramos Mejía Hospital
- Investigators
- Roberto Santa Cruz, Principal investigator, Hospital General Ramos Mejia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192342
- Sponsor's protocol ID
- Observational
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No