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

Apnea Clinical Trial

Official title:
SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02968797
Study type Observational
Source Meir Medical Center
Contact Brian Fredman, MD
Phone 052-278-5127
Email fredman.brian@clalit.org.il
Status Recruiting
Phase
Start date September 1, 2016
Completion date December 1, 2019
View Details
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