Columbia University
New York, 10025, United States
NCT Number: NCT05977153
The goal of this study is to compare two different ways of helping patients with a condition called sepsis who need help breathing using a machine called a ventilator. The investigators want to study which way of setting the ventilator is better for the lungs.
Here are the main questions the investigators want to answer:
1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. How does the way air spreads out in different parts of the lungs differ between the two ways? In this study, the investigators will take special pictures of the lungs using a machine called a CT scan. The pictures will show us how much the lungs stretch and how much air is in different parts of the lungs. The investigators will compare two different ways of using the ventilator: one personalized for each patient based on their breathing, and another way that is commonly used.
By comparing these two ways, the investigators hope to learn which one is better for helping patients with sepsis who need the ventilator. This information can help doctors make better decisions about how to care for these patients and improve their breathing.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
New York, 10025, United States
Mechanical ventilation is a key life support method applied to millions of surgical and critically ill patients. Ventilator-induced lung injury (VILI) is a major factor for morbidity and mortality in patients with the acute respiratory distress syndrome (ARDS), the most severe form of respiratory dysfunction. Furthermore, mechanical ventilation settings also contribute to the risk for postoperative pulmonary complications (PPCs) in surgical patients and lung injury in critically ill patients with normal lungs at onset of ventilation. In summary, mitigation of VILI is critical to reduce perioperative and critical care morbidity and mortality, with major impact on outcomes and health care costs.
In this project, we propose to apply novel CT methods to assess spatial distributions of strain and aeration and establish measures of global lung mechanics best indicative of the PEEP leading to least injurious distributions and, thus, least VILI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Breathing assistance from the breathing assist machine using a method in which doctors try to find the pressures that expands the lungs the best. This is based on measurements of one's respiratory pressures and volumes. This is done by adjusting the pressure settings. This allows one's lungs to expand with the least amount of change in pressure during breathing.
PEEP (positive end-expiratory pressure) will be set at the maximum static respiratory system compliance (Crs) during a descending PEEP titration curve.
Breathing assistance from the breathing assist machine using the pressure settings typical for your disease.
Standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol: PEEP will be set following a routinely used PEEP table according to patients' blood oxygenation status.
Time frame: 48 hours
Squared coefficient of variation (=variance normalized by the squared mean) of the tidal volumetric strain will be obtained and calculated from CT images.
Time frame: 48 hours
Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.
Time frame: 48 hours
Average gas fraction will be obtained and calculated from CT images.
Time frame: 48 hours
Distribution of aeration categories (non-aerated, poorly aerated, normally aerated and hyperinflated regions) will be obtained and calculated from CT images.
Time frame: 48 hours
Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.
Time frame: Up to 5 days
Time during mechanical ventilation will be recorded in days.
Time frame: 48 hours
Inflammatory cytokine is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation; their presence will be measured by assays.
Columbia University
Other
CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study
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