Clinical trial · Interventional
Clinical Utility of Portable Dynamic Chest X Ray (DDR) 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
NCT06538376CI-TRIAL-00096868recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Copd Exacerbation | — | UNRESOLVED | — |
| Acute Rejection of Lung Transplant (Disorder) | — | UNRESOLVED | — |
| Airway Obstruction | — | UNRESOLVED | — |
| Asthma COPD | — | UNRESOLVED | — |
| Atelectasis | — | UNRESOLVED | — |
| Diaphragmatic Paralysis | — | UNRESOLVED | — |
| Hemothorax | — | UNRESOLVED | — |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Pleural Effusion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Portable Dynamic Digital Radiography (DDR) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging
- description
- Dynamic digital radiography (DDR) is a new version of chest radiography from Konica Minolta (KM) that provides more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. DDR scans are dynamic images that have a rate of 15 frames per second (for 7-20 seconds), acting as a mini-fluorography machine with radiation that is only slightly greater than a traditional chest x-ray. Every patient will receive both a DDR scan and a gold standard scan. Each patient's DDR images will be compared to the golden standard that is completed as part of the patient's routine standard of care. For instance, for many ICU patients this includes traditional chest x-rays, ultrasounds or VQ scans.
- interventionNames
- Diagnostic Test: Portable Dynamic Digital Radiography (DDR)
Primary outcomes (2)
- measure
- 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.
- timeFrame
- Up to 2 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- BACKGROUNDHata A, Yamada Y, Tanaka R, Nishino M, Hida T, Hino T, Ueyama M, Yanagawa M, Kamitani T, Kurosaki A, Sanada S, Jinzaki M, Ishigami K, Tomiyama N, Honda H, Kudoh S, Hatabu H. Dynamic Chest X-Ray Using a Flat-Panel Detector System: Technique and Applications. Korean J Radiol. 2021 Apr;22(4):634-651. doi: 10.3348/kjr.2020.1136. Epub 2020 Nov 30. PMID 33289365
- BACKGROUNDFyles F, FitzMaurice TS, Robinson RE, Bedi R, Burhan H, Walshaw MJ. Dynamic chest radiography: a state-of-the-art review. Insights Imaging. 2023 Jun 19;14(1):107. doi: 10.1186/s13244-023-01451-4. PMID 37332064
- BACKGROUNDCe M, Oliva G, Rabaiotti FL, Macri L, Zollo S, Aquila A, Cellina M. Portable Dynamic Chest Radiography: Literature Review and Potential Bedside Applications. Med Sci (Basel). 2024 Feb 7;12(1):10. doi: 10.3390/medsci12010010. PMID 38390860
- BACKGROUNDYamada Y, Ueyama M, Abe T, Araki T, Abe T, Nishino M, Jinzaki M, Hatabu H, Kudoh S. Time-Resolved Quantitative Analysis of the Diaphragms During Tidal Breathing in a Standing Position Using Dynamic Chest Radiography with a Flat Panel Detector System ("Dynamic X-Ray Phrenicography"): Initial Experience in 172 Volunteers. Acad Radiol. 2017 Apr;24(4):393-400. doi: 10.1016/j.acra.2016.11.014. Epub 2016 Dec 15. PMID 27989446
- BACKGROUNDHida T, Yamada Y, Ueyama M, Araki T, Nishino M, Kurosaki A, Jinzaki M, Honda H, Hatabu H, Kudoh S. Time-resolved quantitative evaluation of diaphragmatic motion during forced breathing in a health screening cohort in a standing position: Dynamic chest phrenicography. Eur J Radiol. 2019 Apr;113:59-65. doi: 10.1016/j.ejrad.2019.01.034. Epub 2019 Jan 31. PMID 30927960
- BACKGROUNDYamada Y, Ueyama M, Abe T, Araki T, Abe T, Nishino M, Jinzaki M, Hatabu H, Kudoh S. Difference in diaphragmatic motion during tidal breathing in a standing position between COPD patients and normal subjects: Time-resolved quantitative evaluation using dynamic chest radiography with flat panel detector system ("dynamic X-ray phrenicography"). Eur J Radiol. 2017 Feb;87:76-82. doi: 10.1016/j.ejrad.2016.12.014. Epub 2016 Dec 16.