CT for Personalized Mechanical Ventilation

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:

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; Sepsis Syndrome; Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: PEEP (positive end-expiratory pressure) - standard; Procedure: PEEP (positive end-expiratory pressure) - maximum

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcos F Vidal Melo, MD/PhD; Phone Number: 16178185934; Email: mv2869@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10025
      • Recruiting
      • Columbia University
      • Contact: Gebhard Wagener, MD; Email: gw72@cumc.columbia.edu
      • Contact: Marcos F Vidal Melo, MD/PhD; Phone Number: 617-818-5934; Email: mv2869@cumc.columbia.edu
      • Principal Investigator: Marcos F VIdal Melo, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: ARDSNet; Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.	Procedure: 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.
Experimental: Group 2: Individualized PEEP (positive end expiratory pressure) Strategy; Participants will receive individualized PEEP (positive end-expiratory pressure).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Average gas fraction	Average gas fraction will be obtained and calculated from CT images.	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.	48 hours
Average tidal strain	Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.	48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time during mechanical ventilation	Time during mechanical ventilation will be recorded in days.	Up to 5 days
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Marcos F VIdal Melo, MD/PhD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Computed Tomography; Acute Lung Injury; Registration Analysis; Functional Lung Imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Inflammation; Wounds and Injuries; Shock; Thoracic Injuries; Sepsis; Toxemia; Lung Injury; Systemic Inflammatory Response Syndrome; Ventilator-Induced Lung Injury
• Other Study ID Numbers: AAAT8623; 5R01HL121228-09 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a NIH funded study. Data sharing will follow NIH guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No