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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL121228-09 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ARDSNet | Active Comparator | Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol. |
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| Group 2: Individualized PEEP (positive end expiratory pressure) Strategy | Experimental | Participants will receive individualized PEEP (positive end-expiratory pressure). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEEP (positive end-expiratory pressure) - maximum | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Squared coefficient of variation of the tidal volumetric strain | Squared coefficient of variation (=variance normalized by the squared mean) of the tidal volumetric strain will be obtained and calculated from CT images. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Squared coefficient of variation of aeration | Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images. | 48 hours |
| Average gas fraction |
| Measure | Description | Time Frame |
|---|---|---|
| Time during mechanical ventilation | Time during mechanical ventilation will be recorded in days. | Up to 5 days |
| Detection of Inflammatory cytokines | 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. |
Inclusion Criteria:
Following onset of mechanical ventilation and not longer than 5 days after intubation.
Sepsis as defined by the most recent criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles W. Emala, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10025 | United States |
This is a NIH funded study. Data sharing will follow NIH guidelines.
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D018746 | Systemic Inflammatory Response Syndrome |
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| PEEP (positive end-expiratory pressure) - standard | Procedure | 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. |
|
Average gas fraction will be obtained and calculated from CT images.
| 48 hours |
| Distribution of aeration categories | Distribution of aeration categories (non-aerated, poorly aerated, normally aerated and hyperinflated regions) will be obtained and calculated from CT images. | 48 hours |
| Average tidal strain | Average of voxel level volumetric tidal strain will be obtained and calculated from CT images. | 48 hours |
| 48 hours |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |