Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06538376

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 and Its Diagnostic Value

Led by Brigham and Women's Hospital · Updated on 2025-10-29

230

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

K

Konica Minolta

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of portable dynamic digital radiography (DDR), a new advanced chest X-ray technology, in intensive care unit (ICU) patients. DDR captures dynamic images of lung motion, ventilation, and perfusion at a high frame rate, potentially providing more detailed and quantitative lung function information compared to traditional chest X-rays. This trial aims to test the feasibility and safety of portable DDR in the ICU and to compare its diagnostic value with current standard imaging methods. Participants will receive one to three sets of DDR scans, including 7-second breathing and breath-holding scans. These images will be compared to gold standard clinical exams such as chest X-rays, CT scans, or ventilation-perfusion (VQ) scans. The study will observe how DDR performs in diagnosing lung conditions like diaphragmatic dysfunction, pulmonary embolism, and pulmonary edema, alongside routine clinical imaging. Throughout the study, participants will undergo DDR imaging alongside their routine clinical imaging. Researchers will analyze these images to measure lung motion, diaphragmatic movement, and perfusion. The primary outcomes include assessing the precision of DDR in evaluating cardiopulmonary functions related to the diaphragm and lung motion as well as pulmonary blood flow, over a period of up to two months. The study will monitor safety and diagnostic accuracy while patients receive standard care.

CONDITIONS

Brief Title

Clinical Utility of Portable Dynamic Chest X Ray (DDR) in the ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Patients with or without mechanical ventilation
  • Likely to have lung or diaphragm pathology such as abnormal diaphragmatic movement, lung aeration issues, pulmonary perfusion problems, increased lung water, or swallowing difficulties
  • Written informed consent provided by the participant or legally authorized representative
Not Eligible

You will not qualify if you...

  • Women who are pregnant
  • Prisoners or institutionalized individuals
  • Patients for whom additional radiation is clinically contraindicated
  • Care team does not approve approaching the patient or surrogate
  • Women of child-bearing potential who test positive for pregnancy (pregnancy test given only to premenopausal women without surgical sterilization)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 2 months

Participants undergo portable dynamic digital radiography (DDR) scans and corresponding clinical gold standard imaging to assess lung and diaphragm function.

1 to 3 imaging sessions depending on clinical condition

Long-term Monitoring

Duration - Up to 2 months

Participants may have follow-up imaging to monitor changes in lung and diaphragm function over time.

Follow-up imaging as clinically indicated

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

G

Gyorgy Frendl, MD PhD

P

Poorva Bagchee, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

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.

Yoshitake Yamada, Masako Ueyama, Takehiko Abe...

https://pubmed.ncbi.nlm.nih.gov/27989446

Time-resolved quantitative evaluation of diaphragmatic motion during forced breathing in a health screening cohort in a standing position: Dynamic chest phrenicography.

Tomoyuki Hida, Yoshitake Yamada, Masako Ueyama...

https://pubmed.ncbi.nlm.nih.gov/30927960

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").

Yoshitake Yamada, Masako Ueyama, Takehiko Abe...

https://pubmed.ncbi.nlm.nih.gov/28065378

Decreased and slower diaphragmatic motion during forced breathing in severe COPD patients: Time-resolved quantitative analysis using dynamic chest radiography with a flat panel detector system.

Tomoyuki Hida, Yoshitake Yamada, Masako Ueyama...

https://pubmed.ncbi.nlm.nih.gov/30777216