Status:
ACTIVE_NOT_RECRUITING
CT for Personalized Mechanical Ventilation
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Ventilator-Induced Lung Injury
Sepsis Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2027
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05977153
Start Date
May 10 2023
End Date
August 31 2027
Last Update
September 26 2025
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10025