NCT06538376 · Brigham and Women's Hospital
Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU
What this study is about
Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography.
View original scientific description
Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.
Interventions
DIAGNOSTIC_TEST
Portable Dynamic Digital Radiography (DDR)
(DDR imaging has already been described in the arm/group description). Each patient in the study will receive at least one set of DDR images, which consists of one 7-second scan in which the patient breaths normally, and a second 7-second scan in which the patient holds their breath (or for ventilated patients, an inspiratory pause is placed by the care team). If the patient's conditions warrant it, up to two sets of follow-up scans may be acquired. For instance, in a patient with diaphragmatic dysfunction, imaging may be completed pre- and post- diaphragmatic plication.
Primary outcome measures
I. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of diaphragm and lung motion.
Time frame: Up to 2 months
Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (diaphragmatic motion, lung motion) compared to current standards of care for imaging. Aim I-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary functions. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard images for each of these parameters are: 1\. Diaphragmatic/Lung motion: Ultrasound imaging.
II. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of pulmonary blood flow.
Time frame: Up to 2 months
Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (pulmonary blood flow) compared to current standards of care for imaging. Aim II-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary function. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard image for this parameter is: 1\. Pulmonary blood flow: VQ scan or pulmonary angiograms The comparisons in precision for both diaphragm/lung motion and pulmonary blood flow will be aggregated to determine overall precision of the DDR technology
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Collaborators
Konica Minolta
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations