CT for Personalized Mechanical Ventilation

Launched by COLUMBIA UNIVERSITY · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the best way to help patients with sepsis who need to use a ventilator, which is a machine that assists with breathing. The research is comparing two different methods of setting the ventilator: one that is tailored to each patient’s breathing needs and another that is a standard approach commonly used. The goal is to find out which method helps the lungs work better, especially by looking at how air moves in and out of the lungs using special CT scans.

To participate in this trial, individuals must be between 65 and 74 years old and have started using a ventilator within the last five days due to sepsis, a serious condition caused by infection. Participants can expect to undergo CT scans that will help researchers see how well their lungs are functioning under the two different ventilator settings. It's important to note that some individuals will not be eligible, including those under 18, those with unstable blood pressure or breathing issues, or certain health conditions that could interfere with the study. This research aims to provide valuable insights that could improve care for patients with sepsis in the future.

Gender

ALL

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.