RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-12
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (at least 18 years of age) including both intubated/ventilated and non-intubated patients
  2. * 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.
  3. * The subject or a legally authorized representative has provided written informed consent.
  1. * Special populations, including women with known pregnancy, prisoners, or institutionalized individuals
  2. * Patients where additional radiation is clinically contraindicated
  3. * Care team does not provide assent for approaching patient/surrogate
  4. * For women of child-bearing potential, defined as premenopausal women, a pregnancy test will be administered to determine pregnancy status and confirm eligibility for the study. A pregnancy test will NOT be administered to women who are post-menopausal or have documentation of surgical sterilization.

Contacts and Locations

Study Contact

Gyorgy Frendl, MD PhD
CONTACT
617-732-5910
gfrendl@bwh.harvard.edu
Poorva Bagchee, BS
CONTACT
585-203-2857
pbagchee@bwh.harvard.edu

Principal Investigator

Gyorgy Frendl, MD PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Hiroto Hatabu, MD PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Bruno Madore, PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Gyorgy Frendl, MD PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
  • Hiroto Hatabu, MD PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
  • Bruno Madore, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-12
Study Completion Date2027-11

Study Record Updates

Study Start Date2023-12-12
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • 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