Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
Primary Purpose
Infections - Bacterial, Pneumonia - Bacterial
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
FLIR ONE
Sponsored by
About this trial
This is an interventional diagnostic trial for Infections - Bacterial focused on measuring imaging, diagnostic, pediatrics
Eligibility Criteria
Inclusion Criteria:
- 18 years or younger
- patient at DAGA Memorial Hospital, Nagpur, India
- had chest x-ray within last 24 hours
- consent obtained from one parent
- assent obtained if child is 8 years or older
Exclusion Criteria:
- thermal image cannot be done within 24 hours of chest x-ray
Sites / Locations
- DAGA Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thermal Imaging
Arm Description
imaging using a thermal camera
Outcomes
Primary Outcome Measures
diagnosis of bacterial pneumonia
Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present
Secondary Outcome Measures
diagnosis of additional site of infection possibly related to bacterial pneumonia
Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician
Full Information
NCT ID
NCT02381431
First Posted
March 2, 2015
Last Updated
January 12, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Lata Medical Research Foundation, Nagpur
1. Study Identification
Unique Protocol Identification Number
NCT02381431
Brief Title
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
Official Title
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Lata Medical Research Foundation, Nagpur
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if thermal images can be used instead of a chest x-ray to diagnose bacterial pneumonia in children with signs and symptoms of pneumonia in Nagpur, India. More specifically, the objectives of the study are: 1) to determine if thermal imaging, using a commercial thermal camera can accurately detect the presence of bacterial pneumonia in children receiving a chest x-ray to rule out pneumonia; 2) to evaluate the use of thermal imaging to monitor the course and resolution of pneumonia in children diagnosed with pneumonia; and 3) to determine if thermal imaging can accurately diagnose sites of infection that are suspected to be related to the pneumonia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections - Bacterial, Pneumonia - Bacterial
Keywords
imaging, diagnostic, pediatrics
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thermal Imaging
Arm Type
Experimental
Arm Description
imaging using a thermal camera
Intervention Type
Device
Intervention Name(s)
FLIR ONE
Primary Outcome Measure Information:
Title
diagnosis of bacterial pneumonia
Description
Thermal imaging will be used and compared to the chest x-ray taken within 24 hours to see if bacterial pneumonia is present
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
diagnosis of additional site of infection possibly related to bacterial pneumonia
Description
Thermal imaging will be used to image other potential sites of infection suspected of being related to the bacterial pneumonia if suspected by physician
Time Frame
within same hospital stay
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years or younger
patient at DAGA Memorial Hospital, Nagpur, India
had chest x-ray within last 24 hours
consent obtained from one parent
assent obtained if child is 8 years or older
Exclusion Criteria:
thermal image cannot be done within 24 hours of chest x-ray
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia L Hibberd, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
DAGA Memorial Hospital
City
Nagpur
State/Province
Maharashtra
Country
India
12. IPD Sharing Statement
Learn more about this trial
Use of Mobile Phones for Thermal Imaging of the Chest to Save Lives of Children With Pneumonia in Nagpur, India
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