Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation

Clalit Health Services

Status: Unknown

Conditions: Apnea

Treatments: Device: SafeSed

Study type: Observational

Funder types: Other

Identifiers

NCT02968797

0143-16-MMC

Details and patient eligibility

About

SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.

Full description

Patients performing endoscopy procedures under sedation at the gastro clinic will be monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist. All patients will be monitored using the same two techniques (SafeSed and Capnography). No clinical decisions will be made based upon the data generated by the SafeSed system.

The data from all sources will be compared (post factum) to validate SafeSed performance.

The data collected on the SafeSed prototype will not be used for treatment of the patient.

The comparative analysis will be free vto be used by the sponsor.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• class 1-3 per American Society Anesthesiologists Physical Status Classification
• Subject signed Informed Concent Form

Exclusion criteria

• Pregnancy
• Unresolved pulmonary infection requiring active treatment
• Chronic pulmonary disease
• Any othe medical condition, that treating physician determines participating in the study is unadvisable