Ventilator-Induced Lung InjuryNCT05977153
CT for Personalized Mechanical Ventilation
A study testing PEEP (positive end-expiratory pressure) - maximum and PEEP (positive end-expiratory pressure) - standard in people with Ventilator-Induced Lung Injury and Sepsis Syndrome, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-Induced Lung Injury, Sepsis Syndrome, Mechanical Ventilation Complication
- What is being tested?
- PEEP (positive end-expiratory pressure) - maximum and PEEP (positive end-expiratory pressure) - standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study
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:
Read more
- 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.
Read the 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.
- Being tested
- PEEP (positive end-expiratory pressure) - maximum, PEEP (positive end-expiratory pressure) - standard
- Keywords
- Computed Tomography, Registration Analysis, Functional Lung Imaging, Acute Lung Injury
- Medical subject headings
- Ventilator-Induced Lung Injury, Systemic Inflammatory Response Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP (positive end-expiratory pressure) - maximumProcedure or surgery
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.
PEEP (positive end-expiratory pressure) - standardProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ARDSNet | Active comparator | Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol. Receives: Procedure: PEEP (positive end-expiratory pressure) - standard |
| Group 2: Individualized PEEP (positive end expiratory pressure) Strategy | Experimental | Participants will receive individualized PEEP (positive end-expiratory pressure). Receives: Procedure: PEEP (positive end-expiratory pressure) - maximum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (4)
Squared coefficient of variation of aeration
Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.
Measured: 48 hours
Average gas fraction
Average gas fraction will be obtained and calculated from CT images.
Measured: 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.
Measured: 48 hours
Average tidal strain
Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start10 May 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Charles W. Emala, Columbia University
- Investigators
- Charles W. Emala, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977153
- Sponsor's protocol ID
- AAAT8623
- Other IDs
- 5R01HL121228-09
- Status last verified
- Sep 2025
- First submitted
- 28 Jul 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a NIH funded study. Data sharing will follow NIH guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study
- ClinicalTrials.gov ID
- NCT05977153
- Acronym / sponsor ID
- AAAT8623
- Keywords
- Computed Tomography, Registration Analysis, Functional Lung Imaging, Acute Lung Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ARDSNet | Active comparator | Procedure: PEEP (positive end-expiratory pressure) - standardParticipants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol. |
| Group 2: Individualized PEEP (positive end expiratory pressure) Strategy | Experimental | Procedure: PEEP (positive end-expiratory pressure) - maximumParticipants will receive individualized PEEP (positive end-expiratory pressure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Following onset of mechanical ventilation and not longer than 5 days after intubation.
- Sepsis as defined by the most recent criteria:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP (positive end-expiratory pressure) - maximumBreathing 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. | Procedure or surgery | Group 2: Individualized PEEP (positive end expiratory pressure) Strategy |
| PEEP (positive end-expiratory pressure) - standardBreathing 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. | Procedure or surgery | Group 1: ARDSNet |
Primary outcome
Squared coefficient of variation of the tidal volumetric strain
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.
4 secondary outcomes
Squared coefficient of variation of aeration
Time frame: 48 hours
Average gas fraction
Time frame: 48 hours
Distribution of aeration categories
Time frame: 48 hours
Average tidal strain
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. This is a NIH funded study. Data sharing will follow NIH guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles W. Emala, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP (positive end-expiratory pressure) - maximum and PEEP (positive end-expiratory pressure) - standard in people with Ventilator-Induced Lung Injury and Sepsis Syndrome, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Squared coefficient of variation of the tidal volumetric strain (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.