Using portable dynamic chest X-ray in the ICU

Clinical Utility of Portable Dynamic Chest X-Ray (DDR) in the ICU: Clinical Trial to Demonstrate the Feasibility of Deploying DDR Technology in the ICU - A Study to Prove Its Increased Diagnostic Value

This study is testing a new portable chest X-ray system in the ICU to see if it can give better pictures of lung movement and function compared to regular X-rays and CT scans for critically ill patients.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06538376 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility and safety of a portable dynamic digital radiography (DDR) system in the ICU, which captures high-resolution images of lung motion, ventilation, and perfusion at a rate of 15 frames per second. Participants will receive one to three sets of DDR images that will be compared to traditional imaging methods like chest X-rays and CT scans to assess the diagnostic value of this new technology. The goal is to improve the precision and accuracy of lung assessments in critically ill patients.

Who should consider this trial

Good fit: Ideal candidates include adults at least 18 years old with conditions affecting lung function, such as pulmonary edema or pneumonia.

Not a fit: Patients who are pregnant or have conditions where additional radiation exposure is contraindicated may not benefit from this study.

Why it matters

Potential benefit: If successful, this technology could enhance the diagnostic capabilities for patients with respiratory conditions in the ICU.

How similar studies have performed: While traditional chest radiography has been widely used, the application of portable DDR technology is novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria: Participants must meet all the following inclusion criteria to participate in this study:

* Adults (at least 18 years of age) including both intubated/ventilated and non-intubated patients
* Likely to have pathology related to either, abnormal diaphragmatic excursion and lung aeration, pulmonary perfusion, increased lung water content or all the above, as well as for cricopharyngeal dysfunction/swallowing difficulties at risk for aspiration.
* The subject or a legally authorized representative has provided written informed consent.

Exclusion Criteria: Candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. These criteria are:

* Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
* Patients where additional radiation is clinically contraindicated
* Care team does not provide assent for approaching patient/surrogate
* For women of child-bearing potential, defined as premenopausal women, a pregnancy test will be administered to determine pregnancy status and confirm eligibility for the study. A pregnancy test will NOT be administered to women who are post-menopausal or have documentation of surgical sterilization.

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Gyorgy Frendl, MD PhD — Brigham and Women's Hospital
• Study coordinator: Gyorgy Frendl, MD PhD

Conditions: Pulmonary Edema, Pneumonia, Atelectasis, Pleural Effusion, Acute Rejection of Lung Transplant, Airway Obstruction, Rib Fractures, Acute Copd Exacerbation