230 Participants Needed

Portable Dynamic Chest X-Ray for ICU Patients

GF
PB
Overseen ByPoorva Bagchee, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new portable imaging technology called Dynamic Digital Radiography (DDR) to evaluate its effectiveness and safety in the ICU. DDR captures moving images of the lungs and provides detailed measurements of lung function, potentially offering better diagnostics than standard chest x-rays or CT scans. The trial aims to compare DDR images with regular scans to determine if DDR provides more precise information. Suitable participants for this trial include those in the ICU with breathing issues or lung problems. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance lung diagnostics in critical care settings.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, so it's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this portable DDR machine is safe for ICU patients?

Research has shown that the portable dynamic digital radiography (DDR) machine has already received FDA approval, indicating some level of safety assurance. DDR captures many images quickly, similar to a short video, with radiation levels only slightly higher than a regular chest x-ray. This design ensures it remains safe and gentle on the body.

Although specific safety data from earlier studies is not provided, testing the machine in ICU settings suggests it is expected to be well-tolerated by patients who are already very ill. This trial is the first to use a portable version of DDR in this setting, aiming to confirm its safety and practicality for bedside use.

Overall, since DDR employs technology similar to traditional x-rays and has existing FDA approval, it is expected to be safe for human use.12345

Why are researchers excited about this trial?

Researchers are excited about Portable Dynamic Digital Radiography (DDR) because it offers a more advanced way to assess lung function in ICU patients compared to traditional chest x-rays, ultrasounds, or VQ scans. Unlike standard imaging, DDR captures dynamic images at a rate of 15 frames per second, providing detailed insights into lung motion, ventilation, and perfusion. This method acts like a mini-fluorography machine but with only slightly more radiation than a standard chest x-ray, potentially offering a safer and more informative option for critical care settings.

What evidence suggests that this portable DDR is effective for ICU patients?

Research has shown that Portable Dynamic Digital Radiography (DDR), provided to participants in this trial alongside clinical gold standard imaging, delivers faster image results than older systems, enhancing ICU workflow. DDR captures moving images of the chest, offering detailed views of lung movement, breathing, and blood circulation, which can be more informative than traditional chest X-rays. Specifically, studies have demonstrated that DDR's capability to capture moving images at 15 frames per second can lead to more accurate diagnoses. By offering a clearer picture of lung function, DDR may assist doctors in making better decisions about patient care.12345

Who Is on the Research Team?

BM

Bruno Madore, PhD

Principal Investigator

Brigham and Women's Hospital

HH

Hiroto Hatabu, MD PhD

Principal Investigator

Brigham and Women's Hospital

GF

Gyorgy Frendl, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for ICU patients with various lung conditions like pneumonia, COPD, or rib fractures. It's testing a new portable chest X-ray machine called DDR. To join, patients must be in the ICU and could benefit from advanced lung imaging.

Inclusion Criteria

The subject or a legally authorized representative has provided written informed consent
I likely have issues with my diaphragm or lung function, or I have trouble swallowing.

Exclusion Criteria

Care team does not provide assent for approaching patient/surrogate
Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
Additional radiation is not safe for me.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Comparison

Participants receive one to three sets of DDR images, which are compared to clinical gold standard exams to assess precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.

Up to 2 months

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Portable Dynamic Digital Radiography (DDR)
Trial Overview The trial is studying Portable Dynamic Digital Radiography (DDR), which takes moving images of the lungs to help doctors see how well they're working. It compares these images to standard ones to check if DDR gives better information.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard ImagingExperimental Treatment1 Intervention

Portable Dynamic Digital Radiography (DDR) is already approved in United States for the following indications:

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Approved in United States as Portable Dynamic Digital Radiography for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Konica Minolta

Collaborator

Trials
1
Recruited
230+

Published Research Related to This Trial

The direct digital radiography (DDR) portable x-ray system significantly improved the efficiency of portable radiography, reducing examination duration by 47% compared to the conventional-CR combo, with mean times of 13.4 minutes versus 25.2 minutes respectively.
The DDR system also provided images for review much faster, with an average time of 6.8 minutes for images to become available in the PACS, compared to 19.2 minutes for the conventional system, demonstrating a substantial enhancement in workflow.
Key Performance Indicators for Comparing the Performance of Portable Radiography: Direct Digital Radiography versus Conventional Machine Computed Radiography-A Study in a Nonacute Hospital.Ngan, TL., Wong, ET., Ng, KL., et al.[2019]
In a study involving 23 ICU patients, Fuji computed radiography (FCR) provided superior image quality compared to conventional chest radiographs, particularly in visualizing catheters and endotracheal tubes.
The findings suggest that FCR is clinically useful for portable chest imaging in the ICU setting, enhancing the ability to assess critical medical devices and conditions.
[Clinical application of FCR (Fuji Computed Radiography) for portable chest radiographs in the ICU].Yamada, K., Fujiwara, T., Igari, H., et al.[2011]
Mobile direct detector (DR) chest radiography provides superior image quality compared to computed radiography (CR) for ICU patients, with better delineation of anatomical structures and monitoring devices.
DR allows for a 50% reduction in radiation dose while maintaining high image quality, making it a safer option for bedside chest radiographs in intensive care settings.
Computed radiography versus mobile direct radiography for bedside chest radiographs: impact of dose on image quality and reader agreement.De Boo, DW., Weber, M., Deurloo, EE., et al.[2011]

Citations

Clinical Utility of Portable Dynamic Chest X Ray (DDR) in ...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 ...
Portable Dynamic Chest X-Ray for ICU PatientsResearch shows that Portable Dynamic Digital Radiography (DDR) provides faster image availability compared to older systems, which can improve workflow and ...
Clinical Utility of Portable Dynamic Chest X Ray (DDR) in ...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 ...
Clinical Utility of Portable Dynamic Chest X Ray (DDR) in ...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 ...
Portable Dynamic Chest Radiography: Literature Review and ...Dynamic digital radiography (DDR) is a high-resolution radiographic imaging technique using pulsed X-ray emission to acquire a multiframe cine-loop of the ...
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