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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06538376
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Portable Dynamic Digital Radiography (DDR) — DIAGNOSTIC_TEST
    (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.

Study Details

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.

Key Dates

Start date
Dec 12, 2023
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Portable Dynamic Digital Radiography (DDR) + Clinical Gold Standard Imaging
    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.

Primary Outcome Measure

I. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of diaphragm and lung motion. [ Time Frame: Up to 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Gyorgy Frendl, MD, PhD
[email protected]
6177325910
Gyorgy Frendl, MD, PhD (PRINCIPAL_INVESTIGATOR)
Hiroto Hatabu, MD, PhD (PRINCIPAL_INVESTIGATOR)
Bruno Madore, PhD (PRINCIPAL_INVESTIGATOR)

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Brigham and Women's Hospital· Boston, MA

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