CT for Personalized Mechanical Ventilation

NCT05977153 | Active Not Recruiting

• 2 other identifiers: AAAT86235R01HL121228-09
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 which way of setting the ventilator is better for the lungs. Here are the main questions the investigators want to answer:

1. 1.How does the amount of air in the lungs and the way it moves differ between the two ways?
2. 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.

Conditions

Ventilator-Induced Lung Injury; Sepsis Syndrome; Mechanical Ventilation Complication

Keywords

Computed Tomography; Registration Analysis; Functional Lung Imaging; Acute Lung Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Squared coefficient of variation of aeration

  48 hours

• Average gas fraction

  48 hours

• Distribution of aeration categories

  48 hours

• Average tidal strain

  48 hours

Other Outcomes (2)

• Time during mechanical ventilation

  Up to 5 days

• Detection of Inflammatory cytokines

  48 hours

Study Arms (2)

Group 1: ARDSNet

ACTIVE COMPARATOR

Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.

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).

Procedure: PEEP (positive end-expiratory pressure) - maximum

Interventions

PEEP (positive end-expiratory pressure) - maximum PROCEDURE

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.

Group 2: Individualized PEEP (positive end expiratory pressure) Strategy

PEEP (positive end-expiratory pressure) - standard PROCEDURE

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.

Group 1: ARDSNet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Columbia University

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Systemic Inflammatory Response Syndrome; Acute Lung Injury

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Charles W. Emala, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Henrik H. Bendixen Professor of Anesthesiology, Vice Chair of Research in the Department of Anesthesiology

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: May 10, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)