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Starling Registry Study

NCT04648293 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1207

Last updated 2024-04-16

No results posted yet for this study

Summary

Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. Being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications.

As fluid management and cardiac output determination are linked to better decision-making and improved outcomes in ICU, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management.

This study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.

Conditions

  • Hemodynamic Monitoring

Interventions

DEVICE

Starling

Starling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance that measures the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Baxter Healthcare's Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. Four electrodes are placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bioreactance waveform constructed. This information is used to determine cardiac output, and measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling device.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Caio Plopper, MD · Baxter Healthcare

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2024-02-21
Completion
2024-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648293 on ClinicalTrials.gov