Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03261479 |
| Other study ID # |
2016P000864 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 13, 2016 |
| Est. completion date |
June 1, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
I. BACKGROUND AND SIGNIFICANCE
1. Historical Background
Every day 16,000 children under the age of 5-years die. Although strides have been made
in early diagnosis and treatment of pneumonia, it still accounts for about 15% of deaths
of children under 5-years (1). Unfortunately care providers in low- and middle-income
countries (LMICs) are limited due to lack of resources and training. Chest x-rays are
especially difficult to obtain in these LMICs (14). Ironically, smartphones are readily
available. Since its development in 1960, Forward-Looking Infrared (FLIR) cameras have
made several technological strides. Notably they are now more affordable and compact,
attaching to smartphones. FLIR cameras now have the potential to aid in early diagnosis
and subsequent treatment of childhood pneumonia.
FLIR imaging was first developed in 1956 with military funding at the University of
Chicago. From the 1960s into the 1970s, FLIR technology was modified independently by
both the Air Force and Texas Instruments Inc. for use by military planes (2). Wendell
Smith first documented the use of thermal imaging in medical diagnosis in 1964. Smith
required 6 minutes to take each thermograph of the horses he was studying (3). Multiple
veterinary studies have been performed since then, and now thermal imaging has been
validated as a means to assess musculoskeletal injuries in animals (4,5).
2. Previous Clinical Studies Supporting the Proposed Research
Interestingly, very few clinical studies have been performed to validate the use of
thermal imaging in medical diagnosis for human diseases. The use of thermography to
diagnose lung disease was studied in Russia in 1976, 1981, and 1991 in three separate
studies, but these studies were neither controlled nor randomized (6-8). In 1970 Potanin
demonstrated through a case series that patients with pneumonia had increased overlying
chest temperatures and patients with pulmonary embolism had decreased overlying chest
temperatures (12). The most recent and impactful study evaluating pneumonia with thermal
imaging was a case series performed by Wiecek et al. (2001), which showed that patients
with pneumonia demonstrated a reduction in thermographic signal as they positively
responded to treatment (13). More modern studies have attempted to validate infrared
thermal imaging in measuring the size of brain tumors intra-operatively (9), screening
for fever in children (10), and predicting length of recuperation after burn injuries
(11), among others. However, there has not been a modern study validating thermal
imaging in diagnosing pneumonia.
3. Rationale behind Proposed Research and Potential Benefit to Society
Pneumonia is one of the primary contributors to under-five mortality worldwide. Imaging to
support the diagnosis of pneumonia can be very difficult to obtain in resource-limited
settings due to lack of equipment and trained staff. Easy-to-access imaging of pneumonia with
thermal imaging technology may allow practitioners to diagnose pneumonia earlier and more
accurately, which would lead to decreased morbidity and mortality. In LMICs where x-ray
availability is already limited in peripheral centers, excessive use of these facilities can
lead to consumption of limited medical resources. Validating thermal imaging in the diagnosis
of pneumonia would likely lead to cost savings, and obviation of side effects of
antimicrobials and excessive radiation.
II. SPECIFIC AIMS:
1. To determine whether the FLIR ONE camera can be used to detect differences in a
temperature spectrum that is clinically applicable. Temperature as measured by a
temporal artery thermometer on hospitalized patients can vary from less than 96°
Fahrenheit to over 104° Fahrenheit. The basis of the FLIR ONE camera and the irPNA
application is to detect asymmetry of temperatures. The investigators hope to
demonstrate that this technology has the capability to demonstrate this difference.
2. To validate thermal imaging with the FLIR ONE camera and irPNRA application as a
sensitive modality to diagnose pneumonia. The investigators hope to demonstrate that
there are few false negatives when using this modality to diagnose pneumonia.
3. To validate thermal imaging with the FLIR ONE camera and irPNRA application as a
specific modality to differentiate pneumonia from other pulmonary processes, such as
asthma, pulmonary embolism, and bronchiolitis. The investigators hope to demonstrate
that there are few false positives when using this modality to diagnose pneumonia.
III. SUBJECT SELECTION:
1. Inclusion/Exclusion Criteria
Inclusion criteria are 1) patients 28-days to 17-years of age, 2) who have
respiratory distress, and 3) who receive a chest x-ray. The investigators will
exclude patients with known chronic lung disease.
2. Source of Samples
The investigators will acquire consent from patients and parents in the Pediatric
Intensive Care Unit, (PICU) Pediatric Emergency Department (ED), and Pediatric Wards at
the Massachusetts General Hospital
IV. SUBJECT ENROLLMENT:
1. Methods of Enrollment
Trained clinical research staff will be present in the MGH PICU, pediatric wards,
and ED and identify potential subjects through providers. Additionally, the EPIC
electronic medical record system will be used by qualified research staff (research
assistants, coordinators, managers) to electronically identify patients who may be
potential candidates for the study. Subjects having a chest x-ray taken will be
approached for study participation. This study will not interfere with the
subject's medical care.
If a patient appears to be eligible, the patient's provider will first approach the
subject and ask if they are willing to be approached about a research study. If the
potential subject declines, no further attempts will be made to enroll the subject.
If the subject agrees to speak to someone about research, a study staff member will
approach him or her about participation.
Recruitment will not involve restrictions on socio-demographic factors including
ethnic characteristics. Recruitment will be devoid of any procedures, which could
be construed as coercive.
2. Procedures for Obtaining Informed Consent
At enrollment, in a private room, the investigator/designee will obtain written
informed consent from participants' parent(s) or guardian for this study. During
this encounter, the investigators will remind participants that they are free to
choose to take part in the research or not. The investigators will use a General
Consent Form for the parents/guardians of the patients. Children 14-17 can provide
assent by co-signing the General Template consent form when able. The investigators
will obtain Assent from the subjects verbally, when possible.
3. Treatment Assignment and Randomization
Treatments or changes in the health care plan will not be made based on this research.
V. STUDY PROCEDURES:
1. Study Parameters to be Measured
In addition to obtaining thermal images with the FLIR ONE camera, The investigators
will obtain several patient data points. These include 1) chief complaint, 2)
temporal artery temperature, 3) cutaneous temperature, 4) ambient temperature, 5)
respiratory rate, 6) oxygen saturation, 7) chest x-ray results and relevant data,
8) discharge diagnosis, and 9) disposition. Additional chest x-rays will not be
obtained, the investigators will use x-rays already procured as part of the patient
diagnosis and treatment approach and plan.
2. Drugs to be Used
None
3. Devices to be Used
FLIR ONE camera, attached to an encrypted iPhone. The investigators will also use
the irPNRA application on the iPhone designed by research team member Jim Lewis to
help direct the thermal imaging. The iPhone is encrypted by Partners regulations
and cannot connect to a phone network or the Internet. The iPhone will remain in
'airplane mode' at all times. Biomed has already investigated and approved these
devices.
4. Procedures/Surgical Interventions
None
5. Data to be Collected and when the Data is to be Collected
The investigators will obtain FLIR ONE thermal images within 4 hours of the subject's
chest x-ray. The investigators will also collect the following data: 1) chief complaint,
2) temporal artery temperature, 3) cutaneous temperature, 4) ambient temperature, 5)
respiratory rate, 6) oxygen saturation, 7) chest x-ray results and relevant data, 8)
discharge diagnosis, and 9) disposition. The vitals will be obtained at the time nearest
to the chest x-ray.
Patient data will be collected prior to being de-identified. The investigators will use
the patient name and medical record number to access their chart in the EMR. Then the
following data will be obtained from the chart: 1) chief complaint, 2) temporal artery
temperature, 3) cutaneous temperature, 4) ambient temperature, 5) respiratory rate, 6)
oxygen saturation, 7) chest x-ray results and relevant data, 8) discharge diagnosis, and
9) disposition. The x-rays will be obtained, uploaded to the LifeImage application,
de-identified, and then sent to the radiologist on our research team with the
appropriate study ID. The patient information will then be de-identified and replaced
with a study ID.
VI. BIOSTATISTICAL ANALYSIS:
1. Specific Data Variables to be Collected
The investigators will collect the following variables from the patient chart: 1)
chief complaint, 2) temporal artery temperature, 3) cutaneous temperature, 4)
ambient temperature, 5) respiratory rate, 6) oxygen saturation, 7) chest x-ray
results and relevant data, 8) discharge diagnosis, and 9) disposition.
The investigators will collect the following identifiers from the patient record
prior to de-identifying them: 1) name, 2) DOB, 3) age, 4) gender, and 5) MRN.
Interpretation of the x-rays will be blinded. The x-rays will be uploaded to
LifeImage, de-identified, and then sent to the radiologist on our research team.
The de-identified x-ray images will then be evaluated by the radiologist.
2. Study Endpoints
The investigators will assess for temperature asymmetry with the FLIR ONE thermal
camera with images taken of the chest. The investigators will compare these results
with the results of a chest x-ray taken within the last 12 hours.
3. Statistical Methods
The investigators will compare chest x-ray results to FLIR ONE thermal imaging
results. The investigators will use sensitivity and specificity calculations based
on the positive and negative results from those studies.
4. Power Analysis
Using the standard α = 0.05, sample size = 31, observed false positive (TI+|CXR-) rate
=0.38 and the observed false negative (TI-|CXR+) rate = 0.20, the power (β-1) for the
test applied to the overall population was calculated at 0.26. In order to achieve a
power of 0.80 with the conditions encountered in this study, The investigators would
require 138 patients.
VII. RISKS AND DISCOMFORT:
1. Complications of Surgical/Non-Surgical Procedures
None
2. Drug Side Effects and Toxins
None
3. Device Complications and Malfunctions
The FLIR ONE device is a thermal camera that attaches to an iPhone. Complications
of the device will not affect the patient. If it malfunctions, the investigators
will fix or replace it.
4. Psychosocial (non-medical) Risks
The risk of loss of confidentiality will be minimized by using study IDs on study
documentation to identify subjects. The list linking the study subjects to the
study IDs will be kept in a secure location, with access limited only to staff
directly involved with the research study.
5. Radiation Risks
There are no known radiation risks. As mentioned above, only x-rays obtained as part of
the patient diagnostic and treatment plans will be used. No additional x-rays will be
taken.
VIII. POTENTIAL BENEFITS:
1. Potential Benefits to Participating Individuals
Participants will not receive any direct benefit from their participation in the
study.
2. Potential Benefits to Society
Worldwide, pneumonia is one of the leading causes of mortality in children in the first
5 years of life. In both developed countries and resource poor settings, detection of
bacterial pathogens by culturing blood or other specimens is time consuming, lacks
sensitivity and ranges from difficult in the U.S. to impossible in the developing world.
In the U.S., the inability to determine which children have a bacterial infection
results in excessive use of antibiotics and increased risk of infection with multi-drug
resistant organisms. In the developing world, the consequences are delays in timely
initiation of antibiotic therapy and excessive referral of children for hospitalization
that overwhelms referral facilities. Regardless of setting, there is an urgent need for
point of care diagnostics to determine which children likely have bacterial pneumonia
and will benefit from administration of antibiotics.
Furthermore, aiding diagnosis of pneumonia with thermal imaging may obviate chest x-rays
as the primary diagnostic tool and reduce unnecessary exposure of patients to radiation.
In the PICU and the Wards, it is not uncommon that some patients require daily or even
more frequent chest x-rays. If The investigators are able to validate thermal imaging as
a tool to detect pneumonia, the investigators could potentially minimize the radiation
exposure of these patients.
IX. MONITORING AND QUALITY ASSURANCE:
1. Independent Monitoring of Source Data
Given the relatively small size of this study and the lack of an investigational
agent, there will not be a data and safety monitoring committee set up for the
purpose of evaluating data and safety of the participants. The principal
investigator, as well as the Partners IRB, shall provide oversight and review of
the study protocol throughout the duration of the study.
2. Safety Monitoring
There will be no official safety monitoring. The investigators anticipate the risks
of participation in this research study to be minimal.
3. Outcomes Monitoring
There will be no outcomes monitoring. Treatments or changes in the health care plan
will not be made based on this research.
4. Adverse Event Reporting Guidelines
The principal investigator will review all reports of safety or other concerns within 24
hours of being notified and communicate these to the IRB as per Partners IRB policy
"Reporting Unanticipated Problems Including Adverse Events". The investigators will not
require a DSMB for this study.
