Prizma Device Temperature Measurement
- Conditions
- Temperature Change, Body
- Registration Number
- NCT03340441
- Lead Sponsor
- G Medical Innovations Ltd.
- Brief Summary
The purpose of the study is to evaluate the temperature measurements by the Prizma device.
- Detailed Description
Primary objective of this study is to compare the temperature measured by the PRIZMA to the oral and Armpit temperature measured by a gold standard device in order to develop and evaluate a skin to body temperature conversion table.
Secondary objective is to collect and compare data of ECG, Respiration and SpO2 collected from the Prizma device to the data collected from gold standard devices for reference of noise level and for future development of the PRIZMA device.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Signed written informed consent
- Age above 18 years from both genders
- ASA physical status 1-4
- Hospitalized in internal ward
Exclusion Criteria
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Skin irritation / Atopic dermatitis or any other skin condition at the area of patients palms that might affect his/her ability to hold the device appropriately
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Temperature measurement 3 months Develop and evaluate a skin to body temperature conversion table.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asaf Harofe Medical Center
🇮🇱Rishon leZion, Israel