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Validation of Thermal Imaging to Detect Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03261479
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ryan Carroll, Massachusetts General Hospital

Brief Summary:
The investigators are proposing a two-stage, prospective, cohort study of 138 subjects > 28 days old and < 18 years old with respiratory distress, already getting a chest x-ray as part of their routine clinical care, who will get thermal pictures of their chest at the Massachusetts General Hospital (MGH) Emergency Department, Pediatric Wards, and Pediatric Intensive Care Unit. The thermal cameras will measure skin temperature, by taking a picture, in a non-contact way. The investigators will recruit 138 patients using the FLIR ONE thermal imaging camera for iPhone and the newly designed irPNA application. The FLIR ONE thermal imaging camera will be attached to a study-designated iPhone which will only have the ability to take pictures. This phone will not have the capability to make calls or use the internet. The iPhone will be password protected, as encrypted by Partners regulations. Demographic and diagnostic data will be collected from patient charts.

Condition or disease Intervention/treatment
Pneumonia Diagnostic Test: Thermal image

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Study Type : Observational
Estimated Enrollment : 138 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Thermal Imaging to Detect Pneumonia
Actual Study Start Date : April 13, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Respiratory distress
Inclusion criteria are 1) subjects 28-days to 17-years of age, 2) who have respiratory distress, and 3) who receive a chest x-ray. We will exclude subjects with known chronic lung disease.
Diagnostic Test: Thermal image
We will take a non-invasive thermal image with the FLIR ONE thermal imaging camera that attaches to a study-designated iPhone.




Primary Outcome Measures :
  1. Presence of pneumonia [ Time Frame: 1 year ]
    Compare identification of pneumonia in thermal image to x-rays read by study radiologists


Secondary Outcome Measures :
  1. Clinical diagnosis [ Time Frame: 1 year ]
    Compare identification of pneumonia in thermal image to diagnosis of clinical team



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subjects evaluated in the emergency department, pediatric wards, or intensive care unit for respiratory distress
Criteria

Inclusion Criteria:

  • patients 28-days to 17-years of age
  • respiratory distress
  • receive a chest x-ray

Exclusion Criteria:

  • known chronic lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261479


Contacts
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Contact: Ryan Carroll, MD 7733328178 rcarroll4@mgh.harvard.edu
Contact: Ryan Carroll, MD 6177244380 RCARROLL4@partners.org

Locations
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United States, Massachusetts
Ryan MD Carroll Recruiting
Boston, Massachusetts, United States, 02114
Contact: Ryan Carroll, MD    773-332-8178    rcarroll4@mgh.harvard.edu   
Contact: Ryan Carroll, MD    6177244380    RCARROLL4@partners.org   
Principal Investigator: Ryan Carroll, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ryan Carroll, MD Physician
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Responsible Party: Ryan Carroll, Assistant Pediatrician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03261479    
Other Study ID Numbers: 2016P000864
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Carroll, Massachusetts General Hospital:
pneumonia
thermal imaging
respiratory distress
x-ray
thermal
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections