CT for Personalized Mechanical Ventilation

Mechanical Ventilation Complication Clinical Trial

Official title:

CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977153
• Other study ID #: AAAT8623
• Secondary ID: 5R01HL121228-09
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: February 1, 2025

Study information

• Verified date: July 2023
• Source: Columbia University
• Contact: Marcos F Vidal Melo, MD/PhD
• Phone: 16178185934
• Email: mv2869[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Here are the main questions the investigators want to answer: 1. How does the amount of air in the lungs and the way it moves differ between the two ways? 2. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Injury
• Mechanical Ventilation Complication
• Sepsis
• Sepsis Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia
• Ventilator-Induced Lung Injury

Intervention

Procedure:
• PEEP (positive end-expiratory pressure) - maximum
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) - standard
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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time during mechanical ventilation	Time during mechanical ventilation will be recorded in days.	Up to 5 days
Other	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.	48 hours
Primary	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
Secondary	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
Secondary	Average gas fraction	Average gas fraction will be obtained and calculated from CT images.	48 hours
Secondary	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
Secondary	Average tidal strain	Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.	48 hours