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NCT02968797 Clinical Trial

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

Apnea Clinical Trial

— SafeSed  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02968797
Other study ID # 0143-16-MMC
Secondary ID
Status Recruiting
Phase
First received September 7, 2016
Last updated March 20, 2018
Start date September 1, 2016
Est. completion date December 1, 2019

Study information
Verified date March 2018
Source Meir Medical Center
Contact Brian Fredman, MD
Phone 052-278-5127
Email fredman.brian@clalit.org.il
Is FDA regulated No
Health authority
Study type Observational

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SafeSed
Monitor respiratory parameters

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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