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

• Conditions: Apnea

• Registration Number: NCT02968797
• Lead Sponsor: Meir Medical Center

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-21
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparative data of monitoring respiratory by 2 technologies	4 months	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.

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel