Back to resultsCT for Personalized Mechanical Ventilation
Primary Purpose
Ventilator-Induced Lung Injury, Sepsis Syndrome, Mechanical Ventilation Complication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEEP (positive end-expiratory pressure) - maximum
PEEP (positive end-expiratory pressure) - standard
Sponsored by
About this trial
This is an interventional prevention trial for Ventilator-Induced Lung Injury focused on measuring Computed Tomography, Registration Analysis, Functional Lung Imaging, Acute Lung Injury
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.
Sites / Locations
- Columbia UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1: ARDSNet
Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
Arm Description
Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.
Participants will receive individualized PEEP (positive end-expiratory pressure).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Squared coefficient of variation of aeration
Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.
Average gas fraction
Average gas fraction will be obtained and calculated from CT images.
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.
Average tidal strain
Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.
Full Information
NCT ID
NCT05977153
First Posted
July 28, 2023
Last Updated
July 28, 2023
Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05977153
Brief Title
CT for Personalized Mechanical Ventilation
Official Title
CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
How does the amount of air in the lungs and the way it moves differ between the two ways?
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-Induced Lung Injury, Sepsis Syndrome, Mechanical Ventilation Complication
Keywords
Computed Tomography, Registration Analysis, Functional Lung Imaging, Acute Lung Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: ARDSNet
Arm Type
Active Comparator
Arm Description
Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.
Arm Title
Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
Arm Type
Experimental
Arm Description
Participants will receive individualized PEEP (positive end-expiratory pressure).
Intervention Type
Procedure
Intervention Name(s)
PEEP (positive end-expiratory pressure) - maximum
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PEEP (positive end-expiratory pressure) - standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Squared coefficient of variation of the tidal volumetric strain
Description
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
Secondary Outcome Measure Information:
Title
Squared coefficient of variation of aeration
Description
Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.
Time Frame
48 hours
Title
Average gas fraction
Description
Average gas fraction will be obtained and calculated from CT images.
Time Frame
48 hours
Title
Distribution of aeration categories
Description
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
Title
Average tidal strain
Description
Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Time during mechanical ventilation
Description
Time during mechanical ventilation will be recorded in days.
Time Frame
Up to 5 days
Title
Detection of Inflammatory cytokines
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcos F Vidal Melo, MD/PhD
Phone
16178185934
Email
mv2869@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcos F VIdal Melo, MD/PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos F Vidal Melo, MD/PhD
Phone
617-818-5934
Email
mv2869@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Gebhard Wagener, MD
Email
gw72@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Marcos F VIdal Melo, MD/PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a NIH funded study. Data sharing will follow NIH guidelines.
Learn more about this trial
CT for Personalized Mechanical Ventilation
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