Thermographic Characteristics of Sore Throat by Thermographic Camera (thermography)
Primary Purpose
Fever, Sore Throat
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Thermal camera by Flir -HM series.
Sponsored by
About this trial
This is an interventional diagnostic trial for Fever focused on measuring sore throat, thermal camera photo, normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 5 years and 18 years who attend the primary health clinic for medical treatment with a complaint of sore throat and fever
- The control group will consist of patients with fever aged between 5 years and 18 years who attend the primary health clinic for medical treatment complaint other than sore throat
Exclusion Criteria:
1. Patients who are already treated with antibiotics
Sites / Locations
- Primary Care Clinic of Clalit Health Services
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thermal camera by Flir HM series
Arm Description
all patients in both study and control groups will undergo thermal camera photo of the tonsils by Flir HM series
Outcomes
Primary Outcome Measures
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.
Secondary Outcome Measures
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Correlation between tonsillitis characterized by redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate and temperature of the tonsils as measured by the thermal camera photo.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01782183
Brief Title
Thermographic Characteristics of Sore Throat by Thermographic Camera
Acronym
thermography
Official Title
Thermographic Characteristics of Sore Throat by Thermographic Camera
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Doron Carmi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Thermographic cameras are used to determine temperature and temperature differences. Attempts have been made to use the thermographic camera as a diagnostic tool in clinical practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The camera absorbs infrared radiation which is discharged from the tissue and than translates it to a digital data or a photograph. The camera does not radiate and direct contact with the patient is not needed. The safety is similar to a regular optic camera. No study on thermographic characteristics of inflammation of organs has been published. The purpose of this study is to demonstrate and document these characteristics of inflammation. The correlation between the thermographic imaging and the clinical diagnosis, using routine methods, will be analyzed. The differences of thermographic imaging between an inflamed organ of a subject to a non inflamed same organ of a normal control will also be analyzed. The management of the patient will be by standard practice and will not be influenced by the thermographic camera image and the study outcome.
Detailed Description
Patients aged between 5 years and 18 years, who attend the primary health clinic for medical treatment with a complaint of only sore throat and fever will be offered to participate in the study and have a thermal camera photo of the tonsils. The study group will consist of 100 patients. Fifty patients will be enrolled who present with sore throat and another 50 patients will be enrolled who present to the clinic for any febrile condition other than a sore throat. A parent will sign consent after the parent and child have received an explanation about the study. The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle. The photograph will be saved in the camera and the investigator will not be able to see the photo. The number of the photograph will be listed with the patient name. The investigator will keep the list and only he will have access to the clinical data. Thereafter a standard clinical examination will be performed and all the patients will receive standard medical treatment irrespective of their participation in the study. The description of the tonsils and the pharynx will be recorded in the patient's electronic medical file and will consist of the following information (one or more of the following options): normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate. Patients who will not have the full description as described above will be excluded from analysis from the study. The data will be analyzed descriptively for a correlation between the clinical findings and the thermal photograph
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Sore Throat
Keywords
sore throat, thermal camera photo, normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermal camera by Flir HM series
Arm Type
Experimental
Arm Description
all patients in both study and control groups will undergo thermal camera photo of the tonsils by Flir HM series
Intervention Type
Device
Intervention Name(s)
Thermal camera by Flir -HM series.
Intervention Description
The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle
Primary Outcome Measure Information:
Title
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.
Time Frame
one day
Secondary Outcome Measure Information:
Title
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Description
Correlation between tonsillitis characterized by redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate and temperature of the tonsils as measured by the thermal camera photo.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged between 5 years and 18 years who attend the primary health clinic for medical treatment with a complaint of sore throat and fever
The control group will consist of patients with fever aged between 5 years and 18 years who attend the primary health clinic for medical treatment complaint other than sore throat
Exclusion Criteria:
1. Patients who are already treated with antibiotics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doron Carmi, MD
Phone
972-52-5673018
Email
doroncr@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Gabbay, MD
Phone
972-503433100
Email
urigab@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Carmi, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Clinic of Clalit Health Services
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doron Carmi, MD
Phone
972-52-5673018
Email
doroncr@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Uri Gabbay, MD
Phone
972-50-3433100
Email
urigab@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Doron Carmi, MD
12. IPD Sharing Statement
Learn more about this trial
Thermographic Characteristics of Sore Throat by Thermographic Camera
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