Thermographic Characteristics of Sore Throat by Thermographic Camera

Fever Clinical Trial

— thermography  

Official title:

Thermographic Characteristics of Sore Throat by Thermographic Camera

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01782183
• Other study ID #: COM120017CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 1, 2013
• Last updated: January 26, 2016
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2016
• Source: Clalit Health Services
• Contact: Doron Carmi, MD
• Phone: 972-52-5673018
• Email: doroncr[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

1. 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

2. 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fever
• Pharyngitis
• Sore Throat

Intervention

Device:
• Thermal camera by Flir -HM series.
The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle

Locations

Country	Name	City	State
Israel	Primary Care Clinic of Clalit Health Services	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Doron Carmi

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.		one day	No
Secondary	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.	one day	No