Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU
Recruiting · NCT06538376 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. 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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States