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

NCT06538376 NA RECRUITING

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.

Details

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	RECRUITING
Enrolment	230
Start date	2023-12-12
Completion	2027-11

Conditions

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

Interventions

• Portable Dynamic Digital Radiography (DDR)

Primary outcomes

• 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. — Up to 2 months
  Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (diaphragmatic motion, lung motion) compared to current standards of care for imaging. Aim I-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary functions. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard images for each of these parameters are: 1\. Diaphragmatic/Lung motion: Ultrasound imaging.
• II. Extended clinical trial to study the degree of precision of the Portable DDR technology in assessing the cardiopulmonary functions of pulmonary blood flow. — Up to 2 months
  Hypothesis: The Portable DDR technology can improve the visualization of parameters associated with lung physiology for ICU patients (pulmonary blood flow) compared to current standards of care for imaging. Aim II-1: Determine the diagnostic precision of Portable DDR technology vs. routine standard of care imaging for specific lung pathologies (for example in pre- and post-transplant patients) that affect the mentioned cardiopulmonary function. The DDR's precision will be measured by using the most relevant diagnostic procedure, the gold standard, for the condition will be used as reference to assess both qualitative and semiquantitative or quantitative information yielded by both types of imaging. The golden standard image for this parameter is: 1\. Pulmonary blood flow: VQ scan or pulmonary angiograms The comparisons in precision for both diaphragm/lung motion and pulmonary blood flow will be aggregated to determine overall precision of the DDR technology

Countries

United States