RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States