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

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.

Conditions

• Pulmonary Edema
• Pneumonia
• Atelectasis
• Pleural Effusion
• Acute Rejection of Lung Transplant (Disorder)
• Airway Obstruction
• Rib Fractures
• Acute Copd Exacerbation
• Asthma COPD
• Pulmonary Embolism
• Hemothorax
• Pneumothorax
• Mesothelioma
• Diaphragmatic Paralysis

Interventions

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.

Sponsors & Collaborators

• Konica Minolta

  collaborator UNKNOWN

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Gyorgy Frendl, MD PhD · Brigham and Women's Hospital

• Hiroto Hatabu, MD PhD · Brigham and Women's Hospital

• Bruno Madore, PhD · Brigham and Women's Hospital

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-12

Primary Completion

2026-11-30

Completion

2027-11-30

FDA Device

Yes

Countries

• United States

Study Locations