Portable Dynamic Chest X-Ray for ICU Patients

Recruiting in Palo Alto (17 mi)

Overseen by Bruno Madore, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

Disqualifiers: Pregnancy, Prisoners, Radiation contraindication, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Portable Dynamic Digital Radiography (DDR) for ICU patients?

Research shows that Portable Dynamic Digital Radiography (DDR) provides faster image availability compared to older systems, which can improve workflow and efficiency in hospitals. Additionally, DDR offers lower radiation exposure and cost compared to traditional CT imaging, making it a useful tool for capturing chest images in ICU patients. ^{1 2 3 4 5}

How is the Portable Dynamic Chest X-Ray treatment different from other treatments for ICU patients?

The Portable Dynamic Chest X-Ray treatment, also known as Dynamic Digital Radiography (DDR), is unique because it captures moving images of the chest with low radiation, providing immediate digital results that can be wirelessly transmitted, enhancing efficiency and workflow compared to traditional methods. ^{1 3 5 6 7}

Research Team

Gyorgy Frendl, MD, PhD

Principal Investigator

Brigham and Women's Hospital

Hiroto Hatabu, MD PhD

Principal Investigator

Brigham and Women's Hospital

Bruno Madore, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

I am 18 years or older and may or may not be on a ventilator.

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.

Trial Timeline

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

Treatment Details

Interventions

• Portable Dynamic Digital Radiography (DDR) (Diagnostic Test)

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.

Participant Groups

Group I: Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Konica Minolta

Collaborator

Trials

1

Recruited

230+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The new WLAN-based direct digital radiography (DDR) portable system significantly reduces the time for X-ray images to be available in the Picture Archiving and Communication System (PACS), with an average time of 6.8 minutes compared to 23 minutes for the conventional system, improving efficiency by 70%.

The study evaluated 190 portable chest X-ray examinations, demonstrating that the DDR system streamlines workflow by minimizing procedural steps, which can enhance patient care through quicker access to radiological images.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Enhanced Workflow and Efficiency of the Wireless Local Area Network (WLAN)-Based Direct Digital Radiography (DDR) Portable Radiography. Ngan, TL., Wong, ET., Ng, KL., et al.[2018]

Digital luminescence radiography (DLR) has been successfully used for 3,000 x-ray examinations of the thorax in intensive-care patients since its installation in December 1987, demonstrating its practical application in a clinical setting.

DLR offers significant advantages, including no faulty exposures, the ability to x-ray patients while they are lying in bed, consistent image brightness through histogram selection, and enhanced electronic image processing and storage, leading to improved diagnostic capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thoracic diagnosis at the intensive care unit: digital radiography]. Witte, G., Krug, B.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Dynamic digital radiography (DDR) is a safe and effective alternative to flexible laryngoscopy for diagnosing recurrent laryngeal nerve paralysis, especially during the COVID-19 pandemic.

DDR offers high temporal resolution and does not generate aerosols, making it a lower-risk screening test compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral recurrent laryngeal nerve paralysis diagnosed using dynamic digital radiography during the COVID-19 pandemic. Shibuya, Y., Hirano, K., Machida, H., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application of FCR (Fuji Computed Radiography) for portable chest radiographs in the ICU]. Yamada, K., Fujiwara, T., Igari, H., et al.[2011]

References

1. United States pubmed.ncbi.nlm.nih.gov

Key Performance Indicators for Comparing the Performance of Portable Radiography: Direct Digital Radiography versus Conventional Machine Computed Radiography-A Study in a Nonacute Hospital. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Enhanced Workflow and Efficiency of the Wireless Local Area Network (WLAN)-Based Direct Digital Radiography (DDR) Portable Radiography. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Utility and validity of dynamic chest radiography in cystic fibrosis (dynamic CF): an observational, non-controlled, non-randomised, single-centre, prospective study. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Thoracic diagnosis at the intensive care unit: digital radiography]. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Computed radiography versus mobile direct radiography for bedside chest radiographs: impact of dose on image quality and reader agreement. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Bilateral recurrent laryngeal nerve paralysis diagnosed using dynamic digital radiography during the COVID-19 pandemic. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[Clinical application of FCR (Fuji Computed Radiography) for portable chest radiographs in the ICU]. [2011]