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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02968797

Acronym

SafeSed

Enrollment

100

Registered

2016-11-21

Start date

2016-09-01

Completion date

2019-12-01

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea

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.

Interventions

DEVICESafeSed

Monitor respiratory parameters

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Israel

Contacts

Primary ContactBrian Fredman, MD

fredman.brian@clalit.org.il052-278-5127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026