Comparing two methods of ventilator support for patients with sepsis

CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study

This study is testing two different ways of using ventilators for patients with sepsis to see which method helps their lungs work better and reduces injury.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Columbia University (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (New York, New York)
• Trial ID: NCT05977153 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate two different approaches to mechanical ventilation for patients suffering from sepsis. It will utilize advanced CT imaging techniques to assess lung function and aeration patterns in response to personalized ventilator settings versus standard settings. The primary focus is on understanding how these methods impact lung strain and the distribution of air within the lungs, which is crucial for minimizing ventilator-induced lung injury. By comparing these two approaches, the study seeks to identify the most effective method for improving patient outcomes in critical care settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with sepsis who have recently been placed on mechanical ventilation.

Not a fit: Patients under 18 years of age or those experiencing significant hemodynamic or respiratory instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved mechanical ventilation strategies that reduce lung injury and enhance recovery for patients with sepsis.

How similar studies have performed: Other studies have shown promising results with personalized ventilation strategies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Following onset of mechanical ventilation and not longer than 5 days after intubation.
* Sepsis as defined by the most recent criteria:

  * Life-threatening organ dysfunction caused by a dysregulated host response to infection operationalized by presumed or documented infection and a Sequential \[Sepsis-related\] Organ Failure Assessment (SOFA) score \>= 2 or a change by 2 from the baseline if baseline known to be different from 0;

Exclusion Criteria:

* Age \< 18 years;
* Hemodynamic instability, defined as: systolic blood pressure (SBP) \< 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered "adequately stabilized" if the dose of the vasopressor/inotrope has not been stable for at least one hour;
* Hypoxemia, defined as: PaO2 \< 70 mmHg on an inspired oxygen fraction (FiO2) greater than or equal to 0.9;
* Hemodynamic and/or respiratory instability (as defined, in items 2 and 3) that develop when the patient is mobilized during routine nursing care such as repositioning/washing the patient or changing their bed linens;
* Hemodynamic and/or respiratory instability (as defined, in items 2 and 3) that develop when a 20 second respiratory pause is required to implement the study protocol. This will be tested by inducing such a pause prior to transporting the patient;
* Any acute or chronic condition which, in the opinion of the investigators, might confound the imaging measurements (such as, but not limited to, severe bronchospasm, pulmonary infection, and lung tumor);
* Any acute or chronic condition which, in the opinion of the investigators or managing critical care team, could prevent safe transport to the CT suite.
* "Air leaks" requiring tube thoracotomy (e.g., pneumothorax, bronchopleural fistula);
* Body mass index \> 40 kg/m2;
* Pregnancy (since this is a study that would expose a fetus to radiation risk);
* Patients who have taken part in other research studies involving radiation exposure, or those patients for whom this research radiation history is unavailable at the time of consent.

Where this trial is running

New York, New York

• Columbia University — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Marcos F VIdal Melo, MD/PhD — Columbia University
• Study coordinator: Marcos F Vidal Melo, MD/PhD

Conditions Ventilator-Induced Lung Injury; Sepsis Syndrome; Mechanical Ventilation Complication; Computed Tomography; Registration Analysis; Functional Lung Imaging; Acute Lung Injury