Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538376
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Clinical Utility of Portable Dynamic Chest X Ray DDR in the ICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Chest radiography was introduced to medical practice over a century ago shortly after the discovery of X-rays by Roentgen Since then it has been a key component of the health screening clinical evaluation and the assessments of therapy for billions of people To this day chest radiography remains the most frequently ordered imaging test In this 700-bed tertiary care hospital over 100000 chest radiographs are obtained annually The technique of chest radiography has remained largely unchanged and is seen as a mostly qualitative rather than quantitative tool Chest dynamic X-ray DDR is a new advanced version of chest radiography that provides important quantitative parameters such as lung motion ventilation and perfusion With a dynamic scan of 20-30 seconds sequential images of both lungs are obtained with high temporal resolution during breathing 75-30 frames per second without increasing radiation dose DDR utilizes a dynamic digital radiography DDR technique with a flat-panel detector 2-6 and generates images with a field-of-view FOV that can cover both lungs DDR utilizes detectors with higher sensitivity than those typically used in conventional radiography enabling multiple dynamic time frames to be obtained despite keeping the dose mostly unchanged Compared to conventional radiography computer analysis and image processing of the DDR sequential time frames provide additional valuable metrics that capture motion and other key functions of the lungs while high-quality chest radiographs can also be generated from the recombined frames Chest DDR can be performed in essentially any patient position including standing or sitting to capture lung physiology in a manner representative of daily life Furthermore DDR is inexpensive requires minimal space and enables high throughput which can help reduce medical costs While area-detector CT can provide a higher temporal resolution its FOV cannot entirely cover both lungs and its radiation dose can be prohibitively high Chest DDR offers a unique opportunity to provide dynamic imaging parameters for lung motion and function in a safe practical and cost-effective manner
Recently the portable DDR technology has become available This portable DDR scanner enables applications for non-mobile patients like ICU patients It allows the semi-quantitative or quantitative evaluation of pulmonary perfusion ventilation and diaphragmatic motion ICU patients may have limited access to CT or MRI scanners due to the severity of their condition andor to difficulties associated with support their devices ECMO LVAD etc hence why the portable DDR technology could have an especially meaningful impact on their care The current Radiology team consists of Drs Nishino Wada Valtchinov and Madore The PIs group from Radiology will work in close collaboration with Dr Frendls research team in the BWH ICUs as well as their biostatistician as multidisciplinary team of experts They will also continue cooperation with Mr Tsunomori and Mr Yoneyama These team members already have an established track record of successful collaboration with the PI
The investigators will use the observational study design where two diagnostic imaging modalities will be compared for their ability to best diagnose lung pathologies ie diaphragmatic motion and lung aerationventilation pulmonary perfusion and lung water content These imaging modalities are i the current portable AP chest x-ray CXR-based diagnostic technique and ii the recently developed portable dynamic chest XR DDR technique
The DDR technology has yet to be proven to provide specific benefits for the care of the patients through the improved diagnosis of their pulmonary issues Its ability to provide clinically meaningful additional information on aspects of lung pathologies diaphragmatic motion and lung aerationventilation pulmonary perfusion and lung water content that cannot be clearly discerned from the current portable CXR-based diagnostic technique need to be documented hence the aims
This study design will compare the ability to diagnose those lung pathologies atelectasis pulmonary embolus and pulmonary edema as determined by either the DDR technology or the traditional qualitative portable routine AP CXR the current standards of diagnosis through images obtained via the two techniques at the same time points for each patient The DDR imaging and analysis will provide both qualitative and semi-quantitative data for each patient at all time points
For this study the patients routine portable CXR will serve as the control image when applicable and DDR images will serve as study images for each timepoint For certain clinical conditions the applicable gold standards will be used as controls ie CT angiogram for pulmonary embolus V-Q scans for lung ventilation and perfusion and fluorographic swallowing studies for speech and swallow evaluation
Data derived from these studies will be expected to provide novel and clinically crucial quantitative or semi-quantitative information on the degree of diaphragmatic excursion when the patient is spontaneously ventilating vs when ventilator support is provided This would be crucial for decision making regarding the patients readiness for extubation or inversely when poor excursion of the diaphragms is detected for non-ventilated patients it would support the decision for early implementation of ventilator support Data on lung aeration would also factor into this decision-making process
Currently quantitative or semi-quantitative data regarding these physiologic functions of the lungs are not available Hence why the investigators will focus on validating these novel metrics against clinical scenarios and outcomes The investigators anticipate that this novel technology will better guide clinical decision making like the need for or inversely the safe removal of ongoing ventilator support for our patients
Furthermore the perfusion blood flow assessment component of the image analysis would provide invaluable currently unavailable diagnostic options for those patients for whom CT angiogram is not available to rule outconfirm pulmonary embolism PE CT angiogram is not available for patients who suffer from hemodynamic instability or when it is clinically contraindicated like patients with impending renal failure The added value of the DDR technology for the diagnosis of larger PEs will be assessed in the later stages of this study
Recently the portable DDR technology has become available This portable DDR scanner enables applications for non-mobile patients like ICU patients It allows the semi-quantitative or quantitative evaluation of pulmonary perfusion ventilation and diaphragmatic motion ICU patients may have limited access to CT or MRI scanners due to the severity of their condition andor to difficulties associated with support their devices ECMO LVAD etc hence why the portable DDR technology could have an especially meaningful impact on their care The current Radiology team consists of Drs Nishino Wada Valtchinov and Madore The PIs group from Radiology will work in close collaboration with Dr Frendls research team in the BWH ICUs as well as their biostatistician as multidisciplinary team of experts They will also continue cooperation with Mr Tsunomori and Mr Yoneyama These team members already have an established track record of successful collaboration with the PI
The investigators will use the observational study design where two diagnostic imaging modalities will be compared for their ability to best diagnose lung pathologies ie diaphragmatic motion and lung aerationventilation pulmonary perfusion and lung water content These imaging modalities are i the current portable AP chest x-ray CXR-based diagnostic technique and ii the recently developed portable dynamic chest XR DDR technique
The DDR technology has yet to be proven to provide specific benefits for the care of the patients through the improved diagnosis of their pulmonary issues Its ability to provide clinically meaningful additional information on aspects of lung pathologies diaphragmatic motion and lung aerationventilation pulmonary perfusion and lung water content that cannot be clearly discerned from the current portable CXR-based diagnostic technique need to be documented hence the aims
This study design will compare the ability to diagnose those lung pathologies atelectasis pulmonary embolus and pulmonary edema as determined by either the DDR technology or the traditional qualitative portable routine AP CXR the current standards of diagnosis through images obtained via the two techniques at the same time points for each patient The DDR imaging and analysis will provide both qualitative and semi-quantitative data for each patient at all time points
For this study the patients routine portable CXR will serve as the control image when applicable and DDR images will serve as study images for each timepoint For certain clinical conditions the applicable gold standards will be used as controls ie CT angiogram for pulmonary embolus V-Q scans for lung ventilation and perfusion and fluorographic swallowing studies for speech and swallow evaluation
Data derived from these studies will be expected to provide novel and clinically crucial quantitative or semi-quantitative information on the degree of diaphragmatic excursion when the patient is spontaneously ventilating vs when ventilator support is provided This would be crucial for decision making regarding the patients readiness for extubation or inversely when poor excursion of the diaphragms is detected for non-ventilated patients it would support the decision for early implementation of ventilator support Data on lung aeration would also factor into this decision-making process
Currently quantitative or semi-quantitative data regarding these physiologic functions of the lungs are not available Hence why the investigators will focus on validating these novel metrics against clinical scenarios and outcomes The investigators anticipate that this novel technology will better guide clinical decision making like the need for or inversely the safe removal of ongoing ventilator support for our patients
Furthermore the perfusion blood flow assessment component of the image analysis would provide invaluable currently unavailable diagnostic options for those patients for whom CT angiogram is not available to rule outconfirm pulmonary embolism PE CT angiogram is not available for patients who suffer from hemodynamic instability or when it is clinically contraindicated like patients with impending renal failure The added value of the DDR technology for the diagnosis of larger PEs will be assessed in the later stages of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None