Ventilatory Parameters in Acute Neurological Injury

NCT06192342 | Recruiting

• 1 other identifier: Observational
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Neurologic Decompensation, Acute; Traumatic Brain Injury; Subarachnoid Hemorrhage

Keywords

acute neurological injury, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Correlation between acute neurological injury and mechanical power

  The first 2 days of the patient on mechanical ventilation (MV)

• Correlation between acute neurological injury and ΔP

  The first 2 days of the patient on mechanical ventilation (MV)

• To assess static pressure

  The first 2 days of the patient on mechanical ventilation (MV)

• To assess the respiratory system resistance

  The first 2 days of the patient on mechanical ventilation (MV)

• To assess the driving pressure

  The first 2 days of the patient on mechanical ventilation (MV)

Study Arms (1)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients ≥ 16 years of age with an ANI requiring mechanical ventilation for neurological causes.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramos Mejía Hospital: lead

Study Sites (1)

Roberto Santa Cruz

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

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberto Santa Cruz

  Hospital General Ramos Mejia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto S Santa Cruz, Dr.

CONTACT

+5492966559019; resc.hrrg@gmail.com

Antonella Civile, Dr.

CONTACT

Civileantonella1998@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 5, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-06

Locations

AR (1)