ACTIVE_NOT_RECRUITING

CT for Personalized Mechanical Ventilation

Conditions

Ventilator-Induced Lung Injury Sepsis Syndrome Mechanical Ventilation Complication Computed Tomography Registration Analysis Functional Lung Imaging Acute Lung Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-10

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05977153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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;	* 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.

Inclusion Criteria

Exclusion 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;

* 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.

Contacts and Locations

Principal Investigator

Charles W. Emala, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University

New York, New York, 10025

United States

Collaborators and Investigators

Sponsor: Columbia University

Charles W. Emala, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-10

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-05-10

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

Computed Tomography
Registration Analysis
Functional Lung Imaging
Acute Lung Injury

Additional Relevant MeSH Terms

Ventilator-Induced Lung Injury
Sepsis Syndrome
Mechanical Ventilation Complication