Validation of Thermal Imaging to Detect Pneumonia

NCT03261479 | Terminated

• 1 other identifier: 2016P000864
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

pneumonia; thermal imaging; respiratory distress; x-ray; thermal

Outcome Measures

Primary Outcomes (1)

• Presence of pneumonia

  Compare identification of pneumonia in thermal image to x-rays read by study radiologists

  1 year

Secondary Outcomes (1)

• Clinical diagnosis

  1 year

Study Arms (1)

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

Interventions

Thermal image DIAGNOSTIC_TEST

We will take a non-invasive thermal image with the FLIR ONE thermal imaging camera that attaches to a study-designated iPhone.

Respiratory distress

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects evaluated in the emergency department, pediatric wards, or intensive care unit for respiratory distress

You may qualify if:

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

You may not qualify if:

• known chronic lung disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Ryan MD Carroll

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pneumonia; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ryan Carroll, MD

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Pediatrician

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 25, 2017
• Study Start: April 13, 2016
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)