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Prediction of Hemodynamic Instability in Patients Admitted to the ICU A Prospective, Nonrandomized, Noninterventional Study for Clinical Data Collection

Prediction of Hemodynamic Instability in Patients Admitted to the ICU A Prospective, Nonrandomized, Noninterventional Study for Clinical Data Collection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28259
Enrollment
500
Registered
2018-07-04
Start date
2018-07-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Hypotension Probability Indicator (HPI) ICU patients with pressure waveform data. Voorspeller van hemodynamische instabiliteit middels arteriële en non-invasieve drukcurve bij IC patiënten.

Interventions

Waveform data collection will be directly performed by the Clearsight system and Flotrac system and placed into a de-identified patient database for Edwards to access. In addition to waveform data, de

Sponsors

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 USA Contact: Jos J Settels Sr Distinguished Engineer, R&D Critical Care Edwards Lifesciences BMEYE Hoogoorddreef 60,1101 BE Amsterdam Zuidoost Telephone No.: +31 (0)20 753 3022
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Data of subjects will be included if the subjects meet the following criteria: 1. Subjects must be at least 18 years of age 2. Expected 8 hours ICU admission 3. Subjects or legal representatives must provide signed written informed consent (prospectively or retrospectively) 4. Arterial line present

Exclusion criteria

Exclusion criteria: Subjects will be excluded if invasive BP cannot be measured with the Flotrac according to the Instructions for use of the Flotrac.

Design outcomes

Primary

MeasureTime frame
Hypotension Probability Indicator (HPI)

Contacts

Public ContactA.P.J. Vlaar

Department of Intensive Care Medicine Meibergdreef 9

a.p.vlaar@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)