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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2019-12-01

Brief Summary

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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.

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Detailed Description

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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

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Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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SafeSed

Monitor respiratory parameters

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No