Study Results
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2020-07-03
2022-06-15
Brief Summary
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Detailed Description
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The study will include up to 80 subjects.
The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Blood pressure monitor
The CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h.
Arterial LIne
Continuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected.
Interventions
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Arterial LIne
Continuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to sign an informed consent form
* Monitored by radial arterial line
Exclusion Criteria
* Subjects receiving more than 2-3 l of fluid per 24h
* Subjects with septic shock
* Subjects with distal edema
* Subjects with arms trauma, where the watch is not wearable
* Subjects where the radial artery could not be palpate
* Subjects with life expectancy of less than 24h.
* Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
* Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)
18 Years
ALL
No
Sponsors
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CardiacSense Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Adi Nimrod, MD
Role: PRINCIPAL_INVESTIGATOR
Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center
Locations
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Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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004_BPI_DC_OS
Identifier Type: -
Identifier Source: org_study_id
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