RecruitingNot ApplicableNCT06538376

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


Sponsor

Brigham and Women's Hospital

Enrollment

230 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a portable dynamic chest X-ray device (DDR) used at the bedside in intensive care units. It examines whether this moving X-ray technology can better assess lung function, breathing mechanics, and swallowing difficulties compared to standard static X-rays. **You may be eligible if...** - You are 18 or older and currently a patient in an ICU - You are expected to have abnormal lung aeration, breathing mechanics, or swallowing difficulties - You may be on a ventilator or breathing on your own - A legal representative can provide consent if you are unable to do so **You may NOT be eligible if...** - You are pregnant - You are a prisoner or institutionalized individual (certain protected populations) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPortable 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

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NCT06538376


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