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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeSed | Device | Monitor respiratory parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Comparative data of monitoring respiratory by 2 technologies | Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled to perform endoscopy procedures under sedation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Fredman, MD | Contact | 052-278-5127 | fredman.brian@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Brian Fredman, MD | Israel: Clalit Health bServices | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | 4428331 | Israel |
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| ID | Term |
|---|---|
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| D013568 | Pathological Conditions, Signs and Symptoms |