NCT02968797

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Apnea

Interventions

Type	Name	Description
DEVICE	SafeSed	Monitor respiratory parameters

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-11-21
• Last updated: 2018-03-21

Locations

1 site across 1 country: Israel