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 - A Study to Prove Its Increased Diagnostic Value

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (at least 18 years of age) including both intubated/ventilated and non-intubated patients

• Likely to have pathology related to either, abnormal diaphragmatic excursion and lung aeration, pulmonary perfusion, increased lung water content or all the above, as well as for cricopharyngeal dysfunction/swallowing difficulties at risk for aspiration.

• The subject or a legally authorized representative has provided written informed consent.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Gyorgy Frendl, MD PhD
gfrendl@bwh.harvard.edu
617-732-5910
Backup
Poorva Bagchee, BS
pbagchee@bwh.harvard.edu
585-203-2857
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2027-11
Participants
Target number of participants: 230
Treatments
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.
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Konica Minolta

This content was sourced from clinicaltrials.gov