Prizma Device Temperature Measurement

G Medical Innovations

Status: Unknown

Conditions: Temperature Change, Body

Treatments: Device: Prizma

Study type: Observational

Funder types: Industry

Identifiers

NCT03340441

CLN-7.4.7.10.10

Details and patient eligibility

About

The purpose of the study is to evaluate the temperature measurements by the Prizma device.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

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